Table 1.
Selected representative institutional studies of comparative effectiveness of radiotherapy and radical prostatectomy in high-risk prostate cancer.
| Study type | Representative study | Summary description | Endpoints | Findings related to PCM, OM | Key limitations |
|---|---|---|---|---|---|
| Randomized controlled trial | Lennernäs et al. (4) (accrual 1996–2001) |
89 patients, T1b–T3a, N0, M0 and PSA ≤ 50 ng/ml. All underwent total androgen blockade (6 months). RP vs. XRT + BT. | Self-reported HRQoL. Secondary endpoints: OM, PCM |
10-year results RP−13.3% PCM, 26.7% OM XRT + BT: 4.5% PCM, 20.5% OM No statistically significant differences |
Limited sample size, lack of statistical power |
| Single or limited multi-institutional observational study | Zelefsky et al. (39) Memorial Sloan Kettering (accrual 1993–2002) |
2,380 pts (including 409 NCCN high-risk) with T1c-T3b PCa were treated with intensity-modulated XRT (≥81 Gy) or RP | Primary endpoint: distant metastasis. Secondary endpoint: PCM | 5-year results with 95% CI RP: 1.0% (0.1–7.0%) PCM RT: 3.7% (1.8–7.4%) PCM |
Hazard ratios not reported for high-risk subset. 3–6 months ADT in 56% of patients. No adjuvant ADT in high-risk patients |
| Boorjian et al. (40) Mayo Clinic, Fox Chase (accrual 1988–2004) |
1,847 NCCN high-risk patients, treated with RP or XRT with pelvic nodes included | Systemic progression, PCM, OM | 10-year PCM 8% (RP), 8% (XRT + ADT), and 12% (XRT alone). Worse HR (1.6) for OM for XRT/ADT compared with RP, though not significant for PCM |
56% ADT utilization in XRT cohort, low radiation dose of median 72 Gy XRT | |
| Ciezki et al. (41) Cleveland Clinic (accrual 1996–2012) |
2,557 NCCN high-risk patients, treated with RP or XRT (≥78Gy) or BT (LDR 144 Gy) | PCM, BF, clinical relapse | 5-year results PCM was 5.3% XRT, 3.2% LDR, and 2.8% for RP |
> 6-months duration of ADT in only 26% of patients with XRT | |
| Tilki et al. (42) Chicago Prostate Cancer Center, USA and Martini-Klinik Prostate Cancer Center, Germany (accrual 1992–2013) |
639 patients with Gleason 9–10 treated with RP ± adjuvant RT ± ADT or XRT + BT + ADT (median 6 months) | OM, PCM | 5-year PCM: 21.89% (RP), 3.93% (RP + XRT), 9.83% MaxRP, 27.04% RP + ADT vs. 5-year PCM: 2.22% (MaxRT) |
Surgery and RT comparison cohorts at geographically different centers | |
| Reichard et al. (43) MD Anderson (accrual 2004–2013); comparison with Matched SEER Cohort |
304 patients with NCCN high-risk or very-high-risk treated with RP or XRT + ADT | BF, DM, OM, LF | 5-year OM RP = 4.3% RT + ADT = 1.5% HR NS |
Limited patient number to assess OM or PCM endpoints; only 3.9% of RP patients received adjuvant RT, no PCM reported |
BF, biochemical failure; BT, brachytherapy; DM, distant metastases; Gy, gray; HR, hazard ratio; HRQoL, health-related quality of life; LDR, low-dose-rate; MaxRP, RP followed by adjuvant radiation within 1 year; MaxRT, XRT + brachytherapy ± ADT; OM, overall mortality; NS, not significant; PCM, prostate cancer-specific mortality; PSA, prostate-specific antigen; XRT, external beam radiation therapy.