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Study Title Principal Investigator
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
Not recruiting | Prostate Cancer | Multisite
Bayer Director
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.
Not recruiting | Prostate Cancer | Multisite
Tanya Dorff
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.
Not recruiting | Prostate Cancer | Multisite
Alvaro Martinez
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.
Not recruiting | Prostate Cancer | Multisite
Michael Morris
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.
Not recruiting | Prostate Cancer | Not Multisite
E. Schroeder
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.
Not recruiting | Prostate Cancer | Not Multisite
Tanya Dorff
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
Not recruiting | Prostate Cancer | Multisite
Neeraj Agarwal
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.
Not recruiting | Prostate Cancer | Multisite
Alan Pollack
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.
Not recruiting | Kidney Cancer | Multisite
Jonathan Rosenberg
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.
Not recruiting | Prostate Cancer | Not Multisite
Mitchell Gross
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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.
Not recruiting | Blood Cancer | Multisite
David Quinn
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