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PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Yes
Radiation Oncology (HERSHEY)
Male
18 year(s) or older
NCT05053152
SITE00001224
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.Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Exclusion Criteria:
Evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy.Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Cancer
Experimental drug compared to a placebo/”sugar pill”