A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer (Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial)
Phase 3N = 206NCT00116220
- Population
- Men with localized but unfavorable-risk prostate cancer
- Design
- Randomized trial at academic and community-based medical centers in Massachusetts, December 1995 to April 2001: 206 men with localized but unfavorable-risk prostate cancer were assigned to radiation therapy (RT) alone or RT plus 6 months of androgen suppression therapy (AST). Main outcome: time to all-cause mortality, with a post-randomization analysis stratified by the Adult Comorbidity Evaluation 27 score.
- Primary endpoint
- All-cause mortality
- Arms
- Radiation therapy alone (control): Radiation therapy alone
- RT plus androgen suppression (experimental): Radiation therapy plus 6 months of androgen suppression therapy
- People
- D'Amico AV, senior author Kantoff PW
All-cause mortalityHR 1.8 (95% CI 1.1–2.9)All-cause mortalityHR 4.2 (95% CI 2.1–8.5)All-cause mortalityHR 0.54 (95% CI 0.27–1.10)
Show the numbers
| Endpoint | Analysis | RT plus androgen suppression | Radiation therapy alone | Effect |
|---|---|---|---|---|
| All-cause mortalityRandomized men (n=206)Time to all-cause mortality (main outcome measure) | primarymedian follow-up 7.6 yearsD'Amico 2008 | — | — | HR 1.8 (95% CI 1.1–2.9)P=0.01Hazard ratio is for RT alone relative to RT plus AST (higher with RT alone). 74 deaths overall: 44 with RT alone vs 30 with RT plus AST. Data as of 15 January 2007. |
| All-cause mortalityMen with no or minimal comorbidity (post-randomization stratification by ACE-27 score) | exploratoryD'Amico 2008 | — | — | HR 4.2 (95% CI 2.1–8.5)P<0.001RT alone relative to RT plus AST. 31 vs 11 deaths. Post-randomization subgroup analysis. |
| All-cause mortalityMen with moderate or severe comorbidity (post-randomization stratification by ACE-27 score) | exploratoryD'Amico 2008 | — | — | HR 0.54 (95% CI 0.27–1.10)P=0.08RT alone relative to RT plus AST. 13 vs 19 deaths. Post-randomization subgroup analysis. |
| Endpoint | Analysis | RT plus androgen suppression | Radiation therapy alone | Effect |
|---|---|---|---|---|
| All-cause mortalityRandomized men (n=206)Time to all-cause mortality (main outcome measure) | primarymedian follow-up 7.6 yearsD'Amico 2008 | — | — | HR 1.8 (95% CI 1.1–2.9)P=0.01Hazard ratio is for RT alone relative to RT plus AST (higher with RT alone). 74 deaths overall: 44 with RT alone vs 30 with RT plus AST. Data as of 15 January 2007. |
| All-cause mortalityMen with no or minimal comorbidity (post-randomization stratification by ACE-27 score) | exploratoryD'Amico 2008 | — | — | HR 4.2 (95% CI 2.1–8.5)P<0.001RT alone relative to RT plus AST. 31 vs 11 deaths. Post-randomization subgroup analysis. |
| All-cause mortalityMen with moderate or severe comorbidity (post-randomization stratification by ACE-27 score) | exploratoryD'Amico 2008 | — | — | HR 0.54 (95% CI 0.27–1.10)P=0.08RT alone relative to RT plus AST. 13 vs 19 deaths. Post-randomization subgroup analysis. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| All-cause mortality | 1.8 | 1.1–2.9 |
| All-cause mortality | 4.2 | 2.1–8.5 |
| All-cause mortality | 0.54 | 0.27–1.1 |