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PhII of Prostate Oligomet Radiotherapy w/ or w/o ADT in Oligomet Prostate Ca

Steven Neema Seyedin


A Study On:

  • Prostate

Status:

  • Open

Eligibility

Adult

Interested in joining this trial?

Official Title

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

Get in touch with our study team