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Study Title Principal Investigator
Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
PRIMARY OBJECTIVES: I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi). II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer. OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection. GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG). GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.
Recruiting | Prostate Cancer | Not Multisite
Mitchell Gross
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4P-10-8: PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Nave Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
This is a research study for individuals who have been diagnosed with cancer of the prostate that is getting worse despite receiving hormone treatment. This study will use MDV3100, an experimental drug, that has not been approved for sale to the public by the United States Food and Drug Administration (US FDA) or other government and health regulatory agencies. The purpose of this study is to determine if MDV3100 will help the study participants live longer, if MDV3100 can delay the progression of cancer by increasing the amount of time before the cancer progresses, and to determine the safety of the study drug.MDV3100 is an experimental drug known as an androgen-receptor antagonist (it blocks the activity of the male sex hormones). It directly affects a key mechanism in the body that leads to prostate cancer cell death. Prostate cancers are initially dependent on the male hormone testosterone for growth. Hormonal therapies that lower testosterone or block the ability of testosterone to act at the level of the prostate cancer are currently among the most effective treatments for prostate cancers that have spread to other body organs (metastasized). The effectiveness of hormonal treatments, however, is not permanent, and over time many prostate cancers progress in spite of these treatments. This study is a multicenter, phase 3 double-blind placebo-controlled study. This study is a blinded study, which means that neither the study participants nor the study doctor will know if they are taking MDV3100 or placebo. The experimental drug, MDV3100 is provided as a 40 mg soft gelatin capsule and is indicated at a dose of 160 mg/day administered once daily. The study drug may be taken with or without food.The study drug will be continued as long as the study participant is tolerating the study drug and continues androgen deprivation treatment until confirmed disease progression through imaging.The safety of the study drug will be determined by the frequency of serious adverse events, frequency and severity of adverse events, frequency of study drug discontinuation due to adverse events as well as the frequency of new clinically significant changes in physical examination findings, vital signs, laboratory values and ECGs.The efficacy analyses will be conducted using the intent-to-treat population defined as all randomized participants.The study will be conducted at 225 locations worldwide. About 1,680 people will participate in this study, 10 will be from USC.
Active, not recruiting | Prostate Cancer | Multisite
Tanya Dorff
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SWOG-S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
OBJECTIVES: Primary - To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT). Secondary - To assess the overall survival and objective progression-free survival of this group of patients. - To assess PSA partial response. - To evaluate the qualitative and quantitative toxicity of abiraterone acetate. OUTLINE: This is a multicenter study. Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable. After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.
Active, not recruiting | Prostate Cancer | Multisite
David Quinn
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A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to controls. OUTLINE: Patients are randomized to 1 or 2 treatment arms. ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment and prior to, or on the day of, their first course of chemotherapy on study and at the start of each subsequent course. ARM II: Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
Recruiting | Breast Cancer | Not Multisite
Tanya Dorff
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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
OBJECTIVES: Primary - Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary - Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients. - Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost). - Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments). Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at discretion of treating physician and may include either 3D-conformal RT or intensity-modulated RT. - Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin) subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks after the first LHRH injection, patients undergo radiotherapy as in arm I. After completion of study therapy, patients are followed up periodically.
Recruiting | Prostate Cancer | Multisite
Alvaro Martinez
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma
PRIMARY OBJECTIVES: I. To determine if patients with advanced transitional cell carcinoma treated with bevacizumab, gemcitabine (gemcitabine hydrochloride) and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo. SECONDARY OBJECTIVES: I. To compare the progression-free survival of these two regimens in patients with advanced transitional cell carcinoma. II. To compare the proportion of patients who experience an objective response on each regimen. III. To compare the grade 3 and greater toxicities in patients treated on the two regimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, cisplatin IV over 1 hour, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 7 years.
Active, not recruiting | Kidney Cancer | Multisite
Jonathan Rosenberg
Exercise and Whey Protein Supplementation as Adjunctive Therapy for Patients With Prostate Cancer Receiving Androgen Deprivation Therapy
PRIMARY OBJECTIVES: I. To determine feasibility of conducting a resistance training (RT) and supplementation program in this population, determine patient adherence and inter-patient variability, and estimate the necessary effect sizes for a larger study. SECONDARY OBJECTIVES: I. To examine the effects of a high intensity RT program, with and without whey protein supplement (WPS), on lean body mass (LBM). Enhancing LBM will increase muscle strength, endurance, and physical function leading to improved quality of life. TERTIARY OBJECTIVES: I. To examine the effects of a high intensity RT program with and without WPS on muscle strength, endurance, physical function, and quality of life. II. To examine changes in lymphocyte glutathione (GSH) and the pharmacodynamics of WPS with and without high intensity RT. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive whole body high-intensity RT thrice weekly and whey protein supplementation orally (PO) daily for 12 weeks. ARM II: Patients receive whole body RT as in Arm I. ARM III: Patients receive whey protein supplementation as in Arm I. ARM IV: Patients receive no intervention for 12 weeks. After 12 weeks, patients may receive whole body RT as in Arm II. After completion of study treatment, patients are followed up periodically.
Recruiting | Prostate Cancer | Not Multisite
E. Schroeder
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
Recruiting | Prostate Cancer | Multisite
Neeraj Agarwal
4P-12-1 A Randomized Phase II Trial of Dasatinib plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy
PRIMARY OBJECTIVES: I. To compare the progression-free survival of men with metastatic castration-resistant prostate cancer treated with abiraterone (abiraterone acetate) plus dasatinib to that of men treated with abiraterone alone. SECONDARY OBJECTIVES: I. To describe the toxicity profile of the combination, as well as the rate of prostate-specific antigen (PSA) response, objective responses, and changes in circulating tumor cell (CTC) numbers. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive abiraterone acetate 1000 mg orally (PO) once daily (QD) and prednisone 5 mg PO twice daily (BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive abiraterone acetate and prednisone as patients in arm A. Patients also receive dasatinib 100 mg PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Active, not recruiting | Prostate Cancer | Not Multisite
Tanya Dorff
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A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
OBJECTIVES: Primary - To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. - To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. Secondary - To compare the rates of a PSA ≥ 0.4 ng/mL and rising at 5 years after randomization (secondary biochemical failure endpoint), the development of hormone-refractory disease (3 rises in PSA during treatment with salvage androgen-deprivation therapy), distant metastasis, cause-specific mortality, and overall mortality. - To compare acute and late morbidity based on Common Toxicity Criteria for Adverse Effects (CTCAE), v. 3.0. - To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. - To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms) patterns and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. - To assess the degree, duration, and significant differences of disease-specific health-related quality of life (HRQOL) decrements among treatment arms. - To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP. - To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses. Tertiary - To assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression). - To evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies. - To assess associations between serum levels of beta-amyloid and measures of cognition and mood and depression. - An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system. OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no), prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are randomized to 1 of 3 treatment arms. - Arm I (prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5 days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions). - Arm II (PBRT and short-term androgen-deprivation [STAD]): Beginning 2 months before the start of PBRT, patients undergo STAD, using a combination of antiandrogen and luteinizing hormone-releasing hormone (LHRH) agonist therapy, for a total of 4-6 months. Patients receive antiandrogen therapy comprising either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4 months (started within 1-14 days prior to the LHRH agonist and ending the last day of radiotherapy ± 14 days). Patients receive LHRH agonist injection beginning concurrently with or 2 weeks after the start of antiandrogen therapy. LHRH agonist injection consists of analogs approved by the FDA (or by Health Canada for Canadian institutions) (e.g., leuprolide, goserelin, buserelin, or triptorelin) and may be given in any possible combination (may be given as a single 4-month injection and one to two 1-month injection[s], two 3-month injections, or a 6-month injection), such that the total LHRH agonist treatment time is 4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in arm I. - Arm III (Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months before the start of radiotherapy, patients receive STAD therapy as in arm II. Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions) followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14 fractions). Patients complete the American Urological Association Symptom Index (AUA SI) questionnaire prior to protocol treatment, at week 6 of radiotherapy, and then periodically after completion of study therapy. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
Recruiting | Prostate Cancer | Multisite
Alan Pollack
4P-11-5-A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Non-Metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
Completed | Prostate Cancer | Multisite
David Quinn
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Phase 2 Trial of phenelzine in non-metastatic recurrent prostate cancer
Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United State with a projected annual incidence of ~29,000 deaths in 2013. For most patients, prostate cancer is adequately treated with primary therapy which may include radiation, surgery (radical prostatectomy, or active surveillance. However, in about one third of patients, cancer recurs following primary therapy usually manifested as an asymptomatic rise in plasma prostate specific antigen (PSA) level. Biochemical recurrence (BCR) defines patients with a confirmed elevation in PSA in the absence of clinically detectable metastatic disease. Given the slow disease course of BCR prostate cancer and the frequent occurrence of other life-altering co-morbidities in this patient population, BCR is a very common condition for which there are no clear standards in terms of the composition of timing of potential treatments. We hypothesize that phenelzine will exert an anti-cancer effect demonstrated by decreasing PSA values in biochemical recurrent prostate cancer patients. In this trial, a dose of 60 mg daily is set as the target dose level based on patient tolerance drawn from the experience in patients with depression. The primary objective in this study is to assess the proportion of patients with biochemically recurrent prostate cancer treated with phenelzine who achieve a PSA decline of >/= 50% from baseline. The secondary objectives of this study are to monitor for potential toxicities and/or beneficial effects of phenelzine in prostate cancer without depression, mania or other primary psychiatric diagnosis; to assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine. The exploratory objective is to collect blood and other samples to study the relationship between MAO activity, biomarkers and prostate cancer. The study population for this study will be men with asymptomatic non-metastatic prostate cancer. A total of 46 patients will be enrolled. 23 with non-castrate circulating androgen levels (testosterone > 50 ng/dl); 23 with castrate levels of circulating androgens (testosterone <50 ng/dl). The dose of phenelzine will be 30mg orally twice a day. The starting dose will be 15 mg daily escalated to 30 mg twice a day over 15 days (Please see section 4.1). Laboratory assessments, including plasma PSA at baseline and following every 28 day cycle. Imaging assessment including CT scans of chest/abdomen/pelvis and bone scan at baseline and every 12 weeks or as clinically indicated.
Recruiting | Prostate Cancer | Multisite
Mitchell Gross
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4P-14-4:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill. Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication. In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups: - One group will receive their current treatment along with the investigational medication - One group will receive their current medications along with a placebo The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in. All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.
Active, not recruiting | Prostate Cancer | Multisite
Tanya Dorff
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RTOG 1115: PHASE III TRIAL OF DOSE ESCALATED RADIATION THERAPY AND STANDARD ANDROGEN DEPRIVATION THERAPY (ADT) WITH A GNRH AGONIST VS. DOSE ESCALATED RADIATION THERAPY AND ENHANCED ADT WITH A GNRH AGONIST AND TAK-700 FOR MEN WITH HIGH RISK PROSTATE CANCER
OBJECTIVES: Primary - To evaluate the difference in overall survival of patients with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (androgen-deprivation therapy [ADT] + radiotherapy) and b) standard treatment with the addition of 24 months of steroid 17alpha-monooxygenase TAK-700 (TAK-700). Secondary - To characterize differences between the treatment groups with respect to incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (QOL) among subjects treated with TAK-700. - To compare rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases. - To compare rate and cumulative incidence of clinical failure, defined as prostate-specific antigen (PSA) > 25 ng/mL, documented local disease progression, regional or distant metastasis, or initiation of ADT. - To compare prostate cancer-specific survival and other-cause mortality. - To compare the change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form. - To compare changes in patient-reported QOL as measured by Expanded Prostate Cancer Index Composite (EPIC). - To assess quality-adjusted survival using the EQ-5D. - To compare nadir and average serum testosterone at 12 and 24 months during treatment. - To compare changes in hemoglobin A1C, fasting glucose, and fasting insulin during 24 months of systemic treatment and during the first three years of follow-up. - To compare changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up. - To compare changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up. - To compare the incidence of adverse events ascertained via CTCAE version 4. - To compare the rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up. - To compare the median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up. - To assess cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to risk group (see Disease Characteristics) and type of radiation therapy (RT) boost (intensity-modulated RT (IMRT) vs brachytherapy). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive standard androgen suppression (AS) with a luteinizing hormone-releasing hormone (LHRH) agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 24 months from initiation and oral (PO) antiandrogen (such as flutamide or bicalutamide) beginning 2 months prior and for the duration of radiation therapy (RT). - Arm II: Patients receive the same standard AS with LHRH agonist and oral antiandrogen as in arm 1. Patients also receive steroid 17alpha-monooxygenase TAK-700 (TAK-700) PO twice daily (BID) for 2 years. In both arms, patients undergo IMRT or 3D-conformal RT to the whole pelvis once daily, 5 days a week, for 6-8 weeks. Some patients also receive brachytherapy. Quality of life is assessed via the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale, the Expanded Prostate Cancer Index Composite (EPIC-26), and the EuroQol (EQ-5D) assessments at baseline and periodically during the study. Serum may be collected from some patients for correlative studies. After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Active, not recruiting | Prostate Cancer | Multisite
Eric Chang
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4P-13-5-A Randomized, Open-Label, Phase 2 Study of Sipuleucel-T with Concurrent versus Sequential Administration of Enzalutamide in Men with Metastatic Castrate-Resistant Prostate Cancer
This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide. This study consists of 3 phases. The screening phase will begin at the completion of the informed consent process and continue through registration. The active phase will begin at registration and continue through the post-treatment visit (30 to 37 days following the last study treatment). The long term follow-up (LTFU) phase will begin after the post-treatment visit and will continue until the subject's death or until Dendreon terminates the study.
Active, not recruiting | Prostate Cancer | Multisite
David Quinn
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4P-15-3: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi- Center Controlled Study of Galeterone Compared With Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA Metastatic Castration-Resistant Prostate Cancer
Terminated | Prostate Cancer | Multisite
David Quinn
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ACRIN 6701- Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate
OBJECTIVES: Primary - Determine the test-retest performance, assessed by the repeatability coefficient [RC] of K^trans and gadolinium curve (IAUGC90^bn) and measured by median pixel values of the whole prostate. - Determine the test-retest performance, assessed by the RC of diffusion-weighted imaging (DWI) metrics D(t) and measured by median pixel values of the whole prostate. Secondary - Determine the test-retest performance, assessed by RC of K^trans, IAUGC90^bn, and D(t), and measured by median pixel values of the dominant prostate tumor. - Determine the effect of reader on the RC of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and DWI metrics for whole prostate and tumor nodule target lesion. - Determine whether T1-dependent or T1-independent methods for gadolinium quantification in DCE-MRI studies produce differing values for the RC for K^trans and IAUGC90^bn. - Explore the correlation between DCE-MRI and DWI metrics for both whole prostate and dominant tumor nodule as target lesions. (Exploratory) - Determine whether the "coffee break" approach toward test-retest analysis of quantitative DWI provides a reasonable estimate of the RC of D(t)of the whole prostate, using as the gold standard the RC of D(t) obtained between the two separate MRI visits. (Exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to MRI vendor used (Siemens vs GE vs Philips). Patients receive gadolinium-based contrast IV and undergo DCE-MRI* and DWI 2 imaging at 2-14 days apart prior to treatment initiation. A central reader evaluation of the 2 successive scans is then conducted. NOTE: *At the discretion of the participating sites, the initial MRI visit (MRI SCAN 1) may be supplemented with endorectal-coil imaging per institutional norms.
Unknown status | Prostate Cancer | Not Multisite
Suzanne Palmer
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4P-09-9 A Phase I/II Trial of AN-152 [AEZS-108] in Castration and Taxane-Resistant Prostate Cancer.
This is a research study for advanced prostate cancer. An experimental drug callled AN-152 (it is also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152. The participants tumor will be tested for expression of this receptor (using an old biopsy). If the participants cancer does not have this receptor, participants will not be eligible to participant in this study.This is a phase I (abbreviated dose escalation 3+3 scheme) followed by a single arm, Simon Optimum two- stage design phase II study using the dose selected in Phase I.AN-152 (AEZS-108) is administered intravenously over 2 hours and will be given at the specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.The primary endpoint of this study is clinical benefit will be defined as non-progression at 12 weeks with no Dose Limiting Toxicity or other toxicity requiring termination of treatment. Secondary endpoints are time to overall disease progression, Recist response for participants with measurable disease, PSA response, Time to PSA progression, Toxicity (side effects considered to be at least probably drug-related), an exploratory analysis to evaluate pain palliation will be performed in those participants with a baseline pain score > 1 or pain score 0 with daily analgesic medication use. Pain palliation will be defined as a 2-point decrease without concomittant increase in analgesic medication use, confirmed with a repeat assessment at least 4 weeks later. and overall survival.Participants will continue treatment until death, disease progression, unacceptable toxicity, participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation beyond 6 cycles is left at the discretion of the study doctor.The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37 for the Phase II portion).
Suspended | Prostate Cancer | Not Multisite
Jacek Pinski
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Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below. 1. Primary Objective: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone and prednisone 2. Secondary Objectives: - To assess the grade 3 or higher toxicity profile and compare safety by treatment arm. - To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm. - To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm. - To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival. - To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival. - To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.
Recruiting | Prostate Cancer | Multisite
Michael Morris
4P-14-2: A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
This is a multi-institutional single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected neuroendocrine prostate cancer (NEPC)MLN8237 is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine marker expression. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. Patients will be followed for survival endpoints following completion of this study until death.The Primary objective of the study is the proportion of patients who are free from radiographic progression 6 months following initiation of treatment with MLN8237.The primary endpoint of 6-month radiographic progression-free proportion will be estimated and a 95% confidence interval will be estimated via binomial proportions.
Active, not recruiting | Prostate Cancer | Multisite
Jacek Pinski
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S0702, "A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment.
This study is about Zoledronic acid that falls under a category of drugs called bisphosphonates. Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ). Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone. There is concern about the association of ONJ with bisphosphonate therapy.The primary objective of this study is to prospectively assess, how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment.This is not a treatment study. This study involves collecting information about the treatment with zoledronic acid and collecting information about participants general health and medical history, oral health and dental history and pain assessment through questionnaires.Participants go through some exams, tests or procedures that are part of regular cancer care, like Blood work, Dental exam, Oral x-rays, Medical and dental history, Physical exam.Every six months for up to three years, participants will be asked to provideInformation regarding current treatment for metastatic bone diseaseInformation about any health problems they are havingInformation about their medical history, treatments and physical examInformation regarding their oral health, dental history and exams and pain assessmentIf at any time participants are diagnosed with osteonecrosis of the jaw (ONJ)Every three months for up to three years, they will be asked to provideInformation regarding current treatment for ONJInformation about any health problems they are having with the zoledronic acidInformation regarding oral complications and recent dental proceduresUpdated information on their medical history, physical exam, and treatmentSubmission of dental x-rays and scansThe primary endpoint is the diagnosis of confirmed ONJ. For statistical consideration the goal of this study is to estimate the cumulative incidence rate of confirmed ONJ associated with zoledronic acid at 3 years in patients with bone metastases.About 3,500 people will take part in this study nationally; 200 research participants from USC will take part in this study.
Active, not recruiting | Blood Cancer | Multisite
David Quinn
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4P-12-6 PhII-123 A Randomized Gene Fusion Stratified Phase 2 Trial Of Abiraterone with Or without ABT-888 For Patients with Metastatic Castration-Resistant Prostate Cancer
PRIMARY OBJECTIVES: I. To evaluate the role of v-ets erythroblastosis virus E26 oncogene (ETS) gene fusion as a predictive biomarker for response to hormone therapy (abiraterone [abiraterone acetate]) alone or hormone therapy plus poly adenosine diphosphate-ribose polymerase 1 (PARP-1) targeted therapy (ABT-888 [veliparib]) in patients with metastatic castration resistant prostate cancer. II. To evaluate whether the addition of PARP-1 targeted therapy is superior to hormone therapy alone based on ETS gene fusion status. SECONDARY OBJECTIVES: I. Rate of prostate-specific antigen (PSA) declines. II. Objective response rate. III. Progression-free survival. IV. Evaluate the qualitative and quantitative toxicity of abiraterone acetate with and without ABT-888. TERTIARY OBJECTIVES: I. To determine the concordance in fusion status among prostate cancer samples from the primary site, biopsied metastasis, and circulating tumor cells (CTCs). II. To assess if ETS fusion status in the CTCs, at baseline, 12 weeks, and disease progression (or when off study) is associated with response to therapy. III. To evaluate if the number of CTCs, as well as the expression levels of androgen receptor, RAD51 recombinase (RAD51), and gamma-H2A histone family, member X (H2aX) foci in the CTCs at baseline, at 12 weeks, and at disease progression in all patients is associated with response to therapy. IV. To determine the role of phosphatase and tensin homolog (PTEN) loss as a predictive biomarker of response to abiraterone, alone or in combination with ABT-888. V. To determine the role of PARP1 activity as a predictive biomarker of response to abiraterone, alone or in combination with ABT-888. VI. To perform next-generation sequencing for discovery of novel gene fusions in prostate cancers negative for ETS fusions. VII. To perform germline single nucleotide polymorphism (SNP) analysis of genes involved in hormone synthesis, transport, binding, metabolism, and degradation for discovery of novel SNPs predictive of response to abiraterone, alone or in combination with ABT-888. VIII. To determine if ETS fusion ribonucleic acid (RNA) levels in blood are predictive of response to abiraterone, alone or in combination with ABT-888. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive abiraterone acetate orally (PO) once daily (QD) and prednisone PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.
Active, not recruiting | Prostate Cancer | Multisite
David Quinn
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Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort
PRIMARY OBJECTIVES: I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention on cell proliferation in the prostatectomy tissue. SECONDARY OBJECTIVES: I. To determine the effect of metformin intervention on prostate tissue bioavailability of metformin. II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the prostatectomy tissue. III. To determine the effect of metformin intervention on potential molecular targets of metformin including activated protein kinase (AMPK) activation, mammalian target of rapamycin (mTOR) regulation, and cell cycle regulation in the prostatectomy tissue. IV. To determine the effect of metformin intervention on changes in systemic hormones and growth factors that have been shown to be modulated by metformin in other patient populations including fasting glucose, fasting insulin, insulin-like growth factor axis, testosterone, and sex hormone binding globulin (SHBG). V. To determine the effect of metformin intervention on changes in prostate-specific antigen (PSA) levels. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) for 4-12 weeks. ARM II: Patients receive placebo PO QD for 4-12 weeks. Patients in both arms undergo surgery one day after completion of treatment. After completion of study treatment, patients are followed up within 30 days of surgery.
Completed | Prostate Cancer | Multisite
Mike Nguyen
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A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have Bone Metastases
Active, not recruiting | Prostate Cancer | Multisite
Bayer Director
4P-14-7 - Phase II Randomized, Placebo-Controlled Trial of PROSTVAC? (PSA-TRICOM) in Patients with Clinically Localized Prostate Cancer Undergoing Active Surveillance
An alternative and novel approach for delaying disease progression in men on active surveillance is immunotherapy. This is a Phase II randomized, placebo-controlled, double-blind trial of PROSTVA (a poxviral vaccine), in patients with clinically localized prostate cancer undergoing active surveillance. We plan to recruit men with a diagnosis of localized prostate cancer within 24 months prior to enrollment who are being monitored by active surveillance. Rational: Available data suggest that PROSTVAC improved the overall survival in patients with castration-resistant prostate cancer and the survival benefit increased with less advanced or less aggressive disease. Objectives: The primary objectives of this study are to determine the effects of PROSTVAC on the change (from pre- to post-intervention) in CD8+ and CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies and the correlation between the change in CD8+ and the change in PSA. Population: Men with clinically localized prostate cancer undergoing active surveillance. Study Arms: The study agent is PROSTVAC. Participants will receive subcutaneous injection of PROSTVAC or placebo in the study clinic. Participants will be randomly assigned (2:1) to PROSTVAC or placebo. One injection of PROSTVAC-V (or placebo) at baseline. Six injections of PROSTVAC-F (or placebo) over 140 days. Endpoints: Prostate tissue immune infiltrate - Circulating immune cell subsets - PSA doubling time Tumor extent and grade, and Safety and feasibility. Follow-Up: Study subjects will be followed for 30 days after the end-of-intervention biopsy or 30 days after the last study dose is given, if no end-of-intervention biopsy was performed. Analysis: The primary analysis will be based on the participants with available endpoint data. Multiple imputation techniques based on chained equations will be performed to handle missing outcomes. The analysis based on the imputed datasets will be treated as secondary.
Recruiting | Prostate Cancer | Multisite
Mike Nguyen
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