| Comparison and Outcome | Evidence Base | Findings | Risk of Bias | Consistency | Directness and Precision | SOE Grade |
|---|---|---|---|---|---|---|
| RP vs. WW, All-cause mortality | 2 trials SPCG-415,33,34 PIVOT25 (n=1,426) | SPCG-4: Favors RP at 15 years ARR 6.6%; 95% CI, -1.3% to 14.5% Cumulative incidence: 46.1% vs. 52.7% RR 0.75; 95% CI, 0.61 to 0.92 No significant difference between the interventions at 12 years. ARR 7.1%; 95% CI -0.5 to 14.7%; Cumulative incidence: 32.7% vs. 39.8% (137 vs. 156 deaths) RR 0.82; 95% CI 0.65 to 1.03. PIVOT: No significant difference between the interventions at 12 years. ARR 2.9%; 95% CI, -4.1% to 10.3% (171 [47.0%] vs. 183 [49.9%] deaths; HR 0.88; 95% CI, 0.71 to 1.08. | Medium | Consistent | Direct Imprecise | Insufficient |
| RP vs. WW, PCSM | 2 trials SPCG-415,33,34 PIVOT25 (n=1,426) | SPCG-4: Favors RP at 12 and 15 years ARR 6.1%; 95% CI, 0.2% to 12.0% Cumulative incidence: 14.6% vs. 20.7% RR 0.62; 95% CI, 0.44 to 0.87 PIVOT: No significant difference between the interventions. ARR 2.6%; 95% CI, -1.1 to 6.5. (21 [5.8%] vs. 31 [8.7%] deaths; HR 0.63; 95% CI, 0.36 to 1.09. | Medium | Inconsistent | Direct Imprecise | Insufficient |
| RP vs. WW, QOL | 1 trial SPCG-415,33,34 (n=695) | No significant difference between the interventions at median followup of 12.2 years. | High | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| RP vs. WW, QOL (urinary leakage) | 2 trials SPCG-415,33,34 PIVOT25 (n=1,426) | Favors WW for urinary leakage (2–4 years) SPCG-4: OR 2.3 (95% CI, 1.6 to 3.2) PIVOT: RR 2.69 (95% CI 1.61 to 4.51) | Mediuma | Consistent | Direct Precise | Low |
| RP vs. WW, QOL (erectile dysfunction at 4 years) | 2 trials SPCG-415,33,34 PIVOT25 (n=1,426) | SPCG-4: No significant difference between interventions for erectile dysfunction at 4 years). PIVOT: RR 1.84 (95% CI 1.59 to 2.11) (Favors WW at 2 years) | Medium | Inconsistent | Direct Imprecise | Insufficient |
| RP vs. WW, QOL (bowel dysfunction) | 1 trial PIVOT25 (n=695) | No significant difference between interventions for bowel dysfunction. | Medium | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| RP vs. WW, Progression to metastases | 2 trials SPCG-415,33,34 PIVOT25 (n=1,426) | Favors RP SPCG-4: RR 0.65 (95% 0.47 to 0.88) PIVOT: HR 0.40 (95% CI 0.22 to 0.70) | Medium | Consistent | Direct Precise | Moderate |
| RALRP vs. LRP, QOL (urinary continence, erectile function) | 1 trial45 (n=120) | Favors RALRP at 1 year Urinary continence: 95% vs 83.3%, p=0.042 Erectile function: 80% vs 54.2%, p=0.02 | High | Consistency unknown (single study) | Direct Precise | Insufficient |
| RRP vs. BT, QOL | 1 trial44 (n=200) | No significant difference between the interventions at 5-year followup. | High | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| RPP vs. RRP, QOL (urinary continence, erectile function) | 1 trial46 (n=200) | Favors RRP for erectile function (60% vs 42%, p=0.032) at 2 years; no significant between-group difference in urinary continence | High | Consistency unknown (single study) | Direct Precise (erectile function) Imprecise (urinary continence) | Insufficient |
| 3D-CRT vs. 3D-CRT plus ADT, Overall survival | 1 trial35 (n=206) | Favors 3D-CRT plus ADT at median 7.6-year followup HR 3.0; 95% CI, 1.5 to 6.4 (44 vs. 30 deaths) | Low | Consistency unknown (single study) | Direct Precise | Low |
| 3D-CRT vs. 3D-CRT plus ADT, All-cause mortality | 1 trial35 (n=206) | Favors EBRT plus ADT at median 7.6-year followup HR 1.8 (95% CI, 1.1 to 2.9) | Low | Consistency unknown (single study) | Direct Precise | Low |
| 3D-CRT vs. 3D-CRT plus ADT, PCSM | 1 trial35 (n=206) | Favors 3D-CRT plus ADT at median 7.6-year followup HR 4.1; 95% CI, 1.4 to 12.14 (14 vs. 4 deaths) | Low | Consistency unknown (single study) | Direct Precise | Low |
| EBRT vs. EBRT plus ADT, Overall survival | 1 trial43 (n=1,979) | Favors EBRT plus ADT at median 9.1-year followup HR 1.17; 95% CI, 1.10 to 1.35 (57% vs. 62% survival rate) | Medium | Consistency unknown (single study) | Direct Precise | Insufficient |
| EBRT vs. EBRT plus ADT, PCSM | 1 trial43 (n=1,979) | Favors EBRT plus ADT at median 9.1-year followup HR 1.87; 95% CI, 1.27 to 2.74 (8 vs. 4 deaths) | Medium | Consistency unknown (single study) | Direct Precise | Insufficient |
| EBRT vs. EBRT plus ADT, QOL (sexual function) | 1 trial43 (n=1,979) | Favors EBRT at 1 year OR: 1.72 (1.17 to 2.52), p=0.004 | High | Consistency unknown (single study) | Direct Precise | Insufficient |
| EBRT vs. Cryotherapy, Overall survival | 1 trial47 (n=244) | No significant difference between interventions at 5 years. Difference 1.2 (-6.8–9.2). | Medium | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| EBRT vs. Cryotherapy, PCSM | 1 trial47 (n=244) | No significant difference between interventions at 5 years. Difference 0.3 (-4.8–5.4). | Medium | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| EBRT vs. Cryotherapy, QOL (urinary function) | 1 trial52 (n=244) | Favors cryotherapy (p-value was statistically significant) at 3 years. | High | Consistency unknown (single study) | Direct Precise | Insufficient |
| EBRT vs. Cryotherapy, QOL (bowel function) | 1 trial52 (n=244) | No significant difference between interventions at 3 years. | High | Consistency unknown (single study) | Direct Imprecise | Insufficient |
| EBRT vs. Cryotherapy, QOL (sexual function) | 1 trial52 (n=244) | Favors EBRT at 3 years (p-value was statistically significant) | High | Consistency unknown (single study) | Direct Precise | Insufficient |
| RP vs. EBRT All-cause mortality | 6 studies36-40,42 (n= 22,771) | Favors RP Five of 6 studies found that overall mortality was significantly lower following RP (followup 3–15 years) | High | Consistent | Direct Precise | Low |
| RP vs. EBRT PCSM | 6 studies37-42(n=23,301) | Favors RP All 6 studies found that PCSM was significantly lower following RP (followup 3–15 years) | High | Consistent | Direct Precise | Low |
For the interpretation of SOE grading, see definitions of evidence grades in the Methods section under Strength-of-Evidence Grading.
The evidence base for this outcome contained one medium and one high risk-of-bias study; because of this borderline between medium and high risk the strength of evidence was lowered from moderate to low.
Abbreviations: ADT=Androgen-deprivation therapy; ARR=absolute risk reduction; BT=brachytherapy; CI=confidence interval; 3D-CRT=three-dimensional radiation therapy; EBRT=external beam radiation therapy; HR=hazard ratio; PCSM=prostate cancer–specific mortality; PIVOT=Prostate Intervention Versus Observation Trial; QOL=quality of life; RP=radical prostatectomy; RPP=radical perineal prostatectomy; RRP=radical retropubic prostatectomy; RR=relative risk; SOE=strength of evidence; SPCG-4=Scandinavian Prostate Cancer Group-4; WW=watchful waiting.
From: Discussion
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