Immune Activation and Cellular Response From Enzalutamide Alone or With Radium223 in Men With Metastatic, Castration-Resistant Prostate Cancer
I. To evaluate changes in prostate cancer bone involvement induced by enzalutamide alone or
in combination with radium Ra 223 dichloride (radium 223), specifically extent of prostate
cancer infiltration, androgen receptor (AR) signaling and hormone levels, hematopoietic
composition, apoptosis and proliferation.
II. To evaluate the immune activation of enzalutamide alone, or with radium 223.
I. To describe the adverse event profile for the combination in this patient population.
II. Rate of undetectable prostate specific antigen (PSA) nadir, PSA and alkaline phosphatase
changes, rate of symptomatic skeletal events at 12 months, and rate of PSA and radiographic
progression at 12 months.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive enzalutamide orally (PO) daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. Patients also receive
radium Ra 223 dichloride intravenously (IV) on day 1. Treatment repeats every 28 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive enzalutamide as in Arm I. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1.5 years.
Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance
exercise (CARE) intervention on metabolic dysregulation.
I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
I. To determine the effects of a 4-month CARE intervention on skeletal muscle strength,
physical fitness, and quality of life (QOL).
II. To determine the effects of a 4-month CARE intervention on vascular function.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days
weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during
the CARE sessions.
Arm II: Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16
weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.
After completion of study, patients undergoing CARE are followed up for 4 months.
Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be
superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of
genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that
experience a minimal important decline (MID) in urinary irritation/obstructive and bowel
Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index
Composite (EPIC)-26 at 24 months post completion of therapy.
I. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28
fractions of 2.5 Gy) as measured by disease free survival (DFS).
II. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and
24 months post completion of therapy in terms of HRQOL by having fewer patients that
experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary
irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by
III. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28
fractions of 2.5 Gy) as measured by biochemical failure, overall survival, local failure,
prostate cancer specific survival, and distant metastases.
IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2 = 4/5
disease is predictive for biochemical failure.
I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective
than standard hypofractionated IMRT as measured by the European Quality of Life Five
Dimension Five Level Scale Questionnaire (EQ-5D-5L).
II. To determine if disease characteristics captured on MRI can be used to predict which
patients will respond to SBRT versus hypofractionated IMRT.
III. Collect specimens for future translational research analyses.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo IMRT once daily for 5 fractions per week for 28 fractions over less
than 32 business days.
ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week for 5
fractions over less than 12 business days.
After completion of study treatment, patients are followed up every 6-12 months until death
or study termination.
Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer
I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC)
treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA)
decline of >= 50% from baseline.
I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine
in prostate cancer patients.
II. To assess time to radiographic disease progression for patients with recurrent prostate
cancer treated with phenelzine.
III. To collect blood and other samples to study the relationship between MAO activity and
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of
15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been
treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade <
or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating
investigator. Treatment may continue in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up every 3 months for up to 3
Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer
I. To document the appearance of androgen receptor isoform splice variant 7 (AR-V7)
expression over the course of therapy in castration-resistant prostate cancer (CRPC).
II. To determine whether detectable AR-V7 is associated with a shortened duration of
treatment benefit of abiraterone or enzalutamide.
I. To determine how the presence and expression level of AR-V7 impacts response to docetaxel.
II. To determine at what point AR-V7 arises during androgen deprivation therapy (ADT) and how
its presence and expression corresponds to castration resistance.
I. To determine if androgen receptor isoform splice variants (AR-Vs) other than AR-V7 play a
role in resistance and / or response to the therapies explored in this study.
II. To determine if, in patients who do not express mutations in androgen receptor (AR),
other genetic alterations are associated with treatment outcomes to the therapies explored in
Patients undergo blood collection every 4-12 weeks during ADT, abiraterone and / or
enzalutamide and docetaxel. Patients switched from ADT to either abiraterone or enzalutamide
during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cell-free
ribonucleic acid (cfRNA), cell-free deoxyribonucleic acid (cfDNA), AR-V7, and other AR-Vs via
quantitative reverse transcriptase-polymerase chain reaction (RT-PCR).
After completion of study, patients are followed up for 3 years.
Diagnosing Clinically Significant Prostate Cancer in African American and White Men
Many men with prostate cancer do not need to receive treatment, only monitoring. Therefore, the first step in diagnosing prostate cancer is to do a prostate biopsy to determine whether treatment is needed or not, and to find the most appropriate treatment. Standard biopsy approaches can miss the most aggressive area of cancer, leading to under-diagnosis of disease. We are comparing two new protocols to diagnose prostate cancer that combine the use of imaging and image-guided biopsies, in addition to standard biopsy. Our goal is to improve the detection of clinically significant cancer, so that men can make more confident decisions about their treatment and follow-up.