Blog

Gustavo Viani: Salvage RT Alone or With Hormonal Therapy?

Gustavo Viani/sbradioterapia.com.br

Aug 8, 2025, 08:51

Gustavo Viani: Salvage RT Alone or With Hormonal Therapy?

Gustavo Viani, Associate Professor at Faculty of Medicine of Botucatu, São Paulo State University (UNESP), shared on LinkedIn:

“Salvage RT Alone or With Hormonal Therapy? 18-Year Results Are In.

RTOG 9601 – A Landmark Study in Post-Prostatectomy Management

Why it matters:
Should we combine salvage prostate bed radiotherapy (RT) with anti-androgen therapy (AAT)? The long-awaited 18-year follow-up from the RTOG 9601 trial provides compelling evidence that answers this critical question.

Study Objective

To determine whether 24 months of bicalutamide (150 mg daily) added to salvage RT improves outcomes in men with recurrent prostate cancer post-prostatectomy (PSA 0.2–4.0 ng/mL, pT2/3N0).

Key Results (Median follow-up: 18.9 years):

Overall Survival (OS) at 18 years:

RT + AAT: 53%
RT + Placebo: 43%

HR: 0.82; p = 0.025
Prostate cancer-specific mortality:

18% (AAT) vs. 28% (Placebo)

sHR: 0.63; p = 0.002
Distant metastases:

22% (AAT) vs. 31% (Placebo)

sHR: 0.62; p = 0.001
Biochemical failure (PSA):

49% (AAT) vs. 71% (Placebo)

HR: 0.49; p < 0.001

Clinical Implications

Long-term survival benefits with AAT increased from +5% at 12 years to +10% at 18 years.
Subgroup benefit: Strongest in patients with:
Gleason 8–10
PSA >1.5 ng/mL
Positive margins
Toxicity: No major increase in GU, GI, or CV events. Notable: gynecomastia was more frequent in AAT arm.

Take-home Message

In high-risk patients post-prostatectomy, adjuvant hormonal therapy (AAT) with salvage RT significantly improves overall survival, metastasis-free survival, and cancer-specific survival.

This solidifies the role of combination therapy in selected patients with recurrent prostate cancer.”

Gustavo Viani