Background
Retrospective cohort study from Johns Hopkins University. 635 men with biochemical recurrence after radical prostatectomy between 1982 and 2004, followed for a median of 6 years from time of PSA rise. Patients were grouped by treatment received after recurrence: observation, hormonal therapy alone, or salvage radiotherapy (with or without hormonal therapy).
Interventions and follow up
Arm A: Salvage radiotherapy ± hormonal therapy (n=160)
Arm B: Hormonal therapy alone (n=78)
Arm C: Observation (n=397)
Primary endpoint: Prostate cancer-specific survival
mFollow up: 6 years post-recurrence
Arm B: Hormonal therapy alone (n=78)
Arm C: Observation (n=397)
Primary endpoint: Prostate cancer-specific survival
mFollow up: 6 years post-recurrence
Results
Prostate cancer-specific survival benefit (salvage RT ± hormones vs observation): HR 0.32 (95% CI 0.19–0.54) for salvage RT with hormones; HR 0.43 (95% CI 0.21–0.87) for salvage RT alone
Hormonal therapy alone vs observation: No significant benefit in cancer-specific survival (HR 0.99)
Hormonal therapy alone vs observation: No significant benefit in cancer-specific survival (HR 0.99)
Adverse events
Main adverse events: Retrospective; toxicity data not systematically reported.
Conclusions
Salvage radiotherapy (with or without hormonal therapy) was associated with a significantly reduced risk of prostate cancer-specific death compared with observation or hormonal therapy alone in men with biochemical recurrence after radical prostatectomy. Hormonal therapy alone did not improve prostate cancer-specific survival.
Key Limitations
Key Limitations: Retrospective, single-institution design with high potential for selection bias. Treatment allocation was not randomized; men receiving salvage RT likely had more favorable prognostic features. Endpoint of cancer-specific survival requires long follow-up and is susceptible to attribution bias in retrospective studies. Variable PSA thresholds and RT doses across the study period.
Clinical Context
This study provided early evidence that salvage RT—not hormones alone—reduces cancer-specific mortality, strengthening the rationale for early salvage RT trials. It corroborated the Stephenson nomogram findings and supported current AUA/ASTRO guidelines recommending salvage RT for biochemical recurrence.
References
References: Trock BJ et al, JAMA 2008