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STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences
Yes
Radiation Oncology (HERSHEY)
Male
18 year(s) or older
NCT03809000
STUDY00016786
Inclusion Criteria:
Prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodesPrior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer