OBJECTIVE: The ARO 96-02 trial primarily compared wait-and-see (WS, arm A) with adjuvant radiation therapy (ART, arm B) in prostate cancer patients who achieved an undetectable prostate-specific antigen (PSA) after radical prostatectomy (RP).
Here, we report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy (SRT, arm C).
METHODS AND MATERIALS: For the study, 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins were recruited. After RP, 307 men achieved an undetectable PSA (arms A + B). In 78 patients the PSA remained above thresholds (median 0.6, range 0.05-5.6 ng/mL). Of the latter, 74 consented to receive 66 Gy to the prostate bed, and SRT was applied at a median of 86 days after RP. Clinical relapse-free survival, metastasis-free survival, and overall survival were determined by the Kaplan-Meier method.
RESULTS: Patients with persisting PSA after RP had higher preoperative PSA values, higher tumor stages, higher Gleason scores, and more positive surgical margins than did patients in arms A + B. For the 74 patients, the 10-year clinical relapse-free survival rate was 63%. Forty-three men had hormone therapy; 12 experienced distant metastases; 23 patients died. Compared with men who did achieve an undetectable PSA, the arm-C patients fared significantly worse, with a 10-year metastasis-free survival of 67% versus 83% and overall survival of 68% versus 84%, respectively. In Cox regression analysis, Gleason score ≥8 (hazard ratio [HR] 2.8), pT ≥ 3c (HR 2.4), and extraprostatic extension ≥2 mm (HR 3.6) were unfavorable risk factors of progression.
CONCLUSIONS: A persisting PSA after prostatectomy seems to be an important prognosticator of clinical progression for pT3 tumors. It correlates with a higher rate of distant metastases and with worse overall survival. A larger prospective study is required to determine which patient subgroups will benefit most from which treatment option.
Wiegel T, Bartkowiak D, Bottke D, Thamm R, Hinke A, Stöckle M, Rübe C, Semjonow A, Wirth M, Störkel S, Golz R, Engenhart-Cabillic R, Hofmann R, Feldmann HJ, Kälble T, Siegmann A, Hinkelbein W, Steiner U, Miller K. Are you the author?
Department of Radiation Oncology, University Hospital Ulm, Germany; WiSP, Research Institute Pharma GmbH, Langenfeld, Germany; Department of Urology, University Hospital Homburg/Saar, Germany; Department of Radiation Oncology, University Hospital Homburg/Saar, Germany; Department of Urology, University Hospital Münster, Germany; Department of Urology, University Hospital Dresden, Germany; Department of Pathology, HELIOS Hospital Wuppertal, Germany; Department of Radiation Oncology, University Hospital Giessen-Marburg, Germany; Department of Urology, University Hospital Giessen-Marburg, Germany; Department of Radiation Oncology, General Hospital Fulda, Germany; Department of Urology, General Hospital Fulda, Germany; Department of Radiation Oncology, University Hospital Berlin, Germany; Department of Urology, University Hospital Berlin, Germany.
Reference: Int J Radiat Oncol Biol Phys. 2014 Nov 20. pii: S0360-3016(14)04192-3.