AUA 2017: Best of Randomized Trials

Boston, MA ( In this session, Dr. Yaxley reviewed the best of randomized trials: ProtecT, ASCENDE-RT, and a randomized trial of robotic versus open prostatectomy. ProtecT was a trial of 1,643 men randomized to active monitoring (545), surgery (553), or radiation therapy (545). The primary outcome was prostate cancer specific mortality at 10 years. Prostate cancer specific survival was no different among the arms (p=0.48%) and there was no difference in mortality stratified by PSA, age, Gleason score, or clinical stage. Disease progression (defined as T3/4, ureteric obstruction, or initiation of ADT) occurred in 112 (20.6%) of active monitoring group compared to 46 of patients undergoing surgery and 46 of the radiation therapy arm (p = 0.004). Metastatic disease progression occurred in 33 of the active monitoring group compared to 13 of the surgery and 16 of the radiotherapy groups. A total of 291/545 (53%) in the active monitoring group ultimately received radical treatment by the end of the 10-year study period. Dr. Yaxley commented that low risk cancer should be initially monitored with active surveillance and that mpMRI plays an integral role in this space in Australia.

The ASCEND-RT trial was an analysis of survival endpoints comparing low dose rate (LDR) brachytherapy boost to a dose-escalated external beam (EBRT) boost for NCCN high- and intermediate-risk prostate cancer. Of these, 276 men (69%) had high-risk disease. The primary endpoint was biochemical progression-free survival. At a median follow-up of 6.5 years, men treated with EBRT-boost were twice as likely to experience a biochemical failure (p < 0.001). In men with at least four years’ follow-up, 54% of the LDR boost have an undetectable PSA compared to 8% of the EBRT boost. No significant differences in overall survival or metastasis-free survival were observed. The cumulative incidence of grade 3 events at 5-years was 18.4% for LDR-boost compared to 5.2% for EBRT-boost (p < 0.001). Acute and late toxicity was higher for LDR-boost.

Lastly, Dr. Yaxley discussed his trial of robotic versus open radical prostatectomy. The co-primary endpoints were oncologic outcomes (positive margin status) and functional status (urinary and sexual function). One hundred sixty-three patients were randomized to each arm. There was no difference in sexual function at baseline (59.8 for open versus 63.5 for robotic) or at 12 weeks (35 for open versus 38.9 for robotic, p = 0.18). Similarly, there was no difference in urinary function at baseline (88.79 for open versus 88.5 for robotic) or at 12 weeks (83.8 for open versus 82.5 robotic, p = 0.48). Surgical margins were positive in 10% of open cases compared to 15% of robotic cases (p = 0.21). The median lymph node count was 3.26 for open and 6.5 for robotic (p = 0.004). Perioperative outcomes demonstrated longer operative time, longer average stay, more intraoperative adverse events, and greater blood loss for the open approach. Patients reported less pain at 24h and 1 week for robotic surgery, but this difference did not persist at 6 or 12 weeks. He concluded that there was no demonstrated difference in erectile function, urinary continence, or early oncologic outcomes between open and robotic surgery. Longer term follow-up at 24 months will be reported soon.

Presented By: John Yaxley, FRACS

Written By: Benjamin T. Ristau, MD, Fox Chase Cancer Center, Philadelphia, PA

at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA