Site for PSCI-22-063: NRG-GU011: A Phase II Double-Blinded, Placebo-Controlled Trial Of Prostate Oligometastatic Radiotherapy With Or Without Androgen Deprivation Therapy In Oligometastatic Prostate Cancer (NRG Promethean)

 

Gender: Male

Age: 18 year(s) or older

Healthy Volunteers:

This study is NOT accepting healthy volunteers

NCT Number: NCT05053152

IRB Number: SITE00001224

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Eligibility Criteria:

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.

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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

Conditions: Cancer

Phase: Experimental drug compared to a placebo/”sugar pill”

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Study Locations

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Location	Contacts
Hershey, PA ,