SPCG-4
Scandinavian Prostatic Cancer Group Study Number 4 (SPCG-4): radical prostatectomy versus watchful waiting in early prostate cancer
N = 695
- Population
- Men with newly diagnosed prostate cancer of UICC clinical stage T1b, T1c or T2 (mean age 64.7 years in the 2005 report)
- Design
- From October 1989 through February 1999 (the 2014 full text says December 1999), 695 men with newly diagnosed prostate cancer in UICC clinical stage T1b, T1c or T2 were randomly assigned to watchful waiting (348) or radical prostatectomy (347). Primary end point: death due to prostate cancer, with blinded evaluation of causes of death. Follow-up reported through 2000 (median 6.2 years), 2003, 2009, 2012 and 2017. Required serum PSA below 50 ng/mL and a negative bone scan (2014 full text).
- Primary endpoint
- Prostate cancer mortality
- Arms
- Watchful waiting (control, n = 348): Watchful waiting
- Radical prostatectomy (experimental, n = 347): Radical prostatectomy
- People
- Holmberg L, Scandinavian Prostatic Cancer Group Study Number 4
Prostate cancer mortalityHR 0.50 (95% CI 0.27–0.91)Δ Prostate cancer mortality−4.3 pointsΔ 180-month Prostate cancer mortality−6.1 points
Show the numbers
| Endpoint | Analysis | Radical prostatectomy | Watchful waiting | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityRandomized men (n=695); follow-up complete through 2000Death due to prostate cancer, blinded evaluation of cause of death; proportion of men in each arm | primarymedian follow-up 6.2 yearsHolmberg 2002 | 4.6% | 8.9% | HR 0.50 (95% CI 0.27–0.91)P=0.02Published as relative hazard for prostatectomy vs watchful waiting. 31 of 348 vs 16 of 347 men died of prostate cancer. Death from other causes: 8.9% vs 10.6%. All-cause deaths 62 vs 53 (P=0.31). |
| Prostate cancer mortalityRandomized men (n=695); follow-up complete through December 2009Cumulative incidence of death from prostate cancer, blinded evaluation of cause of death | long term-updatemedian follow-up 12.8 yearsBill-Axelson 2011 | 14.6% at 15 y | 20.7% at 15 y | P=0.01Cumulative incidence at 15 years: difference 6.1 percentage points (95% CI 0.2 to 12.0). Relative risk with surgery 0.62 (95% CI 0.44 to 0.87), Cox model. 81 men (watchful waiting) vs 55 (prostatectomy) died of prostate cancer. Number needed to treat to avert one death: 15 overall and 7 for men younger than 65 years. |
| Endpoint | Analysis | Radical prostatectomy | Watchful waiting | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityRandomized men (n=695); follow-up complete through 2000Death due to prostate cancer, blinded evaluation of cause of death; proportion of men in each arm | primarymedian follow-up 6.2 yearsHolmberg 2002 | 4.6% | 8.9% | HR 0.50 (95% CI 0.27–0.91)P=0.02Published as relative hazard for prostatectomy vs watchful waiting. 31 of 348 vs 16 of 347 men died of prostate cancer. Death from other causes: 8.9% vs 10.6%. All-cause deaths 62 vs 53 (P=0.31). |
| Prostate cancer mortalityRandomized men (n=695); follow-up complete through December 2009Cumulative incidence of death from prostate cancer, blinded evaluation of cause of death | long term-updatemedian follow-up 12.8 yearsBill-Axelson 2011 | 14.6% at 15 y | 20.7% at 15 y | P=0.01Cumulative incidence at 15 years: difference 6.1 percentage points (95% CI 0.2 to 12.0). Relative risk with surgery 0.62 (95% CI 0.44 to 0.87), Cox model. 81 men (watchful waiting) vs 55 (prostatectomy) died of prostate cancer. Number needed to treat to avert one death: 15 overall and 7 for men younger than 65 years. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Prostate cancer mortality | 0.5 | 0.27–0.91 |
Appears in
Sources
Holmberg L, Bill-Axelson A, Helgesen F, Salo JO, Folmerz P, Häggman M, et al. A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer. N Engl J Med. 2002;347(11):781-9.
Bill-Axelson A, Holmberg L, Ruutu M, Garmo H, Stark JR, Busch C, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 2011;364(18):1708-17.