SAN DIEGO, CA USA (UroToday.com) - At the 2013 annual meeting of the AUA, Dr. Richard Valicenti (chair, radiation oncology, University of California, Davis) presented the new guideline for the use of radiation therapy (RT) following prostatectomy. The guideline represents a joint effort between the AUA and the American Society of Therapeutic Radiation Oncology (ASTRO). Prior to this consensus, there were “no guidelines from a major organization for postoperative radiation for men at high risk of relapse,” said Dr. Valicenti. The scientific rationale for a benefit to postoperative RT exists, and the purpose of the guideline was to provide a framework for use of RT in the salvage or adjuvant setting to improve local disease control, and perhaps survival. Adjuvant RT is defined as RT administered post-prostatectomy because of adverse pathologic features in patients at higher risk of recurrence. Adjuvant RT is administered prior to evidence of disease recurrence, whereas salvage RT is utilized in the setting of PSA recurrence in the absence of detectable metastatic disease. 324 relevant articles were reviewed between January 1990 and December 2012. Statements were presented as standards (benefits outweigh risks/burdens), recommendations (based on level C evidence), or options (benefits equal risks), with evidence rated as A (high; RCTs with high generalizability), B (moderate; RCTs with weakness, moderately strong observational studies), or C (low; observational studies with weaknesses and/or that are inconsistent).
The completion of three major trials made formation of the guidelines possible. SWOG 8794 revealed that adjuvant RT following radical prostatectomy (RP) for patients with pT3N0M0 PCa significantly reduced the risk of metastasis and increased overall survival. In EORTC 22911, biochemical progression free-survival and clinical progression-free survival were significantly improved in the RT group (median follow-up 5 years). Finally, the German ARO96-02 trial showed adjuvant RT following R0 or R1 resection in patients with pT3 PCa decreased the risk of BCR by approximately 50% (compared to observation).
A total of 9 statements were reviewed (5 principles, 2 recommendations, 1 standard, and 1 option). Patients undergoing radical prostatectomy (RP) should be informed of the possibility of radiation following surgery (Clinical Principle) if adverse pathologic findings are present. Adjuvant RT should be offered to patients with adverse pathologic findings, including seminal vesicle invasion, positive surgical margins, and extracapsular extension (Standard; Grade A), as adjuvant RT can reduce the risk of BCR, local recurrence, and clinical progression when compared to RP alone (Standard; Grade A). “Offered” means the care team should engage in a shared decision-making process with patients (Grade A). Patients should be informed that development of PSA recurrence is associated with a higher risk of development of metastatic prostate cancer or death from the disease, and PSA should be regularly monitored post-operatively (Clinical Principle). Biochemical recurrence is defined as a PSA ≥ 0.2 ng/mL, with a second confirmatory PSA (Recommendation; Grade C). Restaging evaluation should be considered in patients with biochemical recurrence (Option; Grade C). In patients with biochemical recurrence and no evidence of metastatic disease, salvage RT should be offered (Recommendation; Grade C). Candidates for salvage RT should be informed that the effectiveness of RT is greatest at low PSA levels (Clinical Principle). Finally, patients should be informed of the possible short-term and long-term urinary, bowel, and sexual side effects of RT as well as of the potential benefits of controlling disease recurrence (Clinical Principle).
Presented by Richard K. Valicenti, MD at the American Urological Association (AUA) Annual Meeting - May 4 - 8, 2013 - San Diego Convention Center - San Diego, California USA
UC Davis Medical Center, Sacramento, CA USA
Reported for UroToday.com by Jeffrey J. Tomaszewski, MD
