RTOG-0534

A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy

Principal Investigator

Alan Pollack, MD, PhD

Status

Disease Site

Genitourinary [GU] Prostate

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) [maintenance of a PSA less than the nadir+2 ng/mL, absence of clinical failure and absence of death from any cause] for 5 years, over that of PBRT alone in men treated with salvage RT after radical prostatectomy; To determine whether NC-STAD+PLNRT+PBRT improves FFP over that of NC-STAD+PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy.

Patient Population

Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy. Post-radical prostatectomy PSA of > = 0.1 – < 2.0 ng/mL; pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin; Gleason < = 9

Target Accrual

1764