Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men with High-Risk PSA-Recurrent Prostate Cancer after Radical Prostatectomy (SALV-ENZA)
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to study the safety and effectiveness of adding a study drug called enzalutamide to radiation treatments for men, who have rising PSA levels following prostatectomy surgery. Enzalutamide is a newer and more potent version of drugs that are sometimes used in combination with radiation treatments for prostate cancer already. This combination with older enzalutamide-like drugs have shown promising results in men with prostate cancer. Enzalutamide blocks an important protein that keeps prostate cancer cells alive and may make prostate cancer cells more resistant to radiation treatments. Enzalutamide is approved by the Food and Drug Administration (FDA) for the treatment of metastatic castrate-resistant prostate cancer (CRPC). It is not approved for use in non-metastatic hormone naïve prostate cancer and its use in this study is considered investigational. The FDA is allowing the use of enzalutamide in this research study.The primary endpoint of this study is freedom-from-PSA-progression (FFPP).
1. Adult male 18 years of age or above in good physical condition2. Confirmed adenocarcinoma of the prostate3. Primary treatment with radical prostatectomy4. Rising PSA after prostatectomy (between 0.2 and 5.0 ng/mL)5. Pathological Gleason (pG) sum 8-10; or pG sum 7 and either pT3 or R1 disease (i.e. positive margins)6. No metastatic disease7. No history of seizures
Patients who take part in this study will be randomly assigned (by chance, like the flip of a coin) to one of the two study groups:1)Placebo - a placebo is an inactive substance that looks like the study drug, but contains no study drug.2)Enzalutamide - blocks the effects of testosterone made by your testicles and other organs in your body. The placebo or enzalutamide will be taken once daily for 6 months. Every patient in the study will receive the same radiation treatment, which will be given Monday-Friday for two months. You will take placebo/enzalutamide for 2 months, then receive radiation for two months while continuing daily placebo/enzalutamide, followed by 2 months of placebo/enzalutamide beginning the day after radiation ends.
01/19/2020 05:03 AM