A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG PROMETHEAN)
Details
This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.
Eligibility
You can join if...
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration
The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug
Exclusion Criteria:
Currently on androgen deprivation or anti-androgen therapy
Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for >= 3 years
Prior chemotherapy for prostate cancer or bilateral orchiectomy