Background
Phase III RCT (GETUG-AFU 16). 743 patients with biochemical recurrence after radical prostatectomy (detectable PSA 0.2–2.0 ng/mL) at 35 French centers. Patients had pN0 or pNx disease. Updated analysis with median follow-up 112 months.
Interventions and follow up
Arm A: Salvage radiotherapy (66 Gy) + goserelin 3.6 mg every 28 days × 6 months (n=374)
Arm B: Salvage radiotherapy (66 Gy) alone (n=369)
Primary endpoint: Progression-free survival
mFollow up: 112 month
Arm B: Salvage radiotherapy (66 Gy) alone (n=369)
Primary endpoint: Progression-free survival
mFollow up: 112 month
Results
PFS at 5 years: 80% (RT + goserelin) vs 62% (RT alone), HR 0.50 (95% CI 0.38–0.66), P<.0001
Metastasis-free survival: Improved with combined approach (HR 0.73)
OS: No statistically significant difference at current follow-up
Metastasis-free survival: Improved with combined approach (HR 0.73)
OS: No statistically significant difference at current follow-up
Adverse events
Main adverse events: Hot flushes significantly higher in goserelin arm. Grade ≥3 toxicity was low overall. Sexual dysfunction more common with combined therapy. No significant increase in cardiovascular events.
Conclusions
Addition of 6 months of goserelin to salvage radiotherapy significantly improved progression-free survival and metastasis-free survival compared with salvage RT alone in men with biochemical recurrence after prostatectomy. Short-course ADT (6 months) is feasible with manageable toxicity.
Key Limitations
Key Limitations: No OS benefit demonstrated at this analysis. 6-month duration of ADT is shorter than the 24-month bicalutamide regimen in RTOG 9601, limiting direct comparison. Optimal patient selection for ADT addition (PSA level, Gleason score, PSA doubling time) remains undefined. Pelvic nodal irradiation not included — SPPORT subsequently addressed this.
Clinical Context
GETUG-AFU 16 established short-course goserelin as the preferred hormonal approach when adding ADT to salvage RT, offering a less toxic alternative to the 24-month bicalutamide regimen from RTOG 9601. Combined with RTOG 9601 and SPPORT, these trials define current practice of risk-adapted ADT addition and pelvic nodal coverage in post-prostatectomy salvage RT.
References