At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed cT1-T2 adenocarcinoma of prostate with radical prostatectomy and lymph node dissection
- ✓At least one poor prognostic feature: seminal vesicle invasion (pT3b), bladder neck involvement (T4), extracapsular extension (pT3a) with Gleason ≥7, organ-confined (pT2) with positive margin and Gleason 8-10, or preoperative PSA >20
- ✓SWOG performance status 0-1
- ✓PSA nadir ≤0.1 ng/mL within 30 days prior to randomization; randomization within 120 days of prostatectomy
- ✕Small cell histology
- ✕N1 or M1 disease
- ✕Clinical T3 disease prior to prostatectomy
- ✕Any investigational therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment
In Brief
A Phase 3 clinical trial evaluating Docetaxel and Prednisone for Prostate Cancer. Completed, enrolled 298 participants across 34 sites in 2 countries.
Detailed Summary
VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for patients who are potentially cured by radical prostatectomy but who are at high risk for relapse. The standard of care is surveillance, with the addition of androgen deprivation at the time of biochemical relapse. This study will assess the effect of adding early chemotherapy to the standard of care on progression free survival in Veterans at high risk for progression after prostatectomy.
Study Details
Timeline
Interventions
Chemotherapy agent
steroid in combination with chemotherapy agent