SUO 2016: EAU Lecture: ProtecT trial - Session Highlights


San Antonio, Texas USA (UroToday.com) Prostate cancer is a global and common problem. The ProtecT trial was designed to assess the effectiveness of active monitoring (AM), radical prostatectomy (RP) and radiation for localized prostate cancer diagnosed by a PSA testing program.


The primary end point was cancer specific survival (CSS) at 10 years while secondary endpoints were overall survival (OS), progression and Quality of life (QoL) outcomes. The recruitment of patients was done by primary care physician and GP nurses in order to prevent a bias in treatment allocation. Patients were fit men, 50-69 years old fit men. PSA was tested after the patients were counseled on prostate cancer and informed consent was obtained. Patients who had an elevated PSA underwent TRUS biopsy at a local hospital. Patients diagnosed with localized disease were randomized into one of the 3 treatment arms. 1643 patients underwent randomization and followed. Most patients (68%) had PSA<6 and 77% had Gleason 6.

Approximately 80% of men in the AM arm had no sign of progression but more than half of them (56%) received radical treatment within 10 years. CSS was 99% with no difference between the treatment arms. OS was 90% at 10 years, again, with identical results between the treatment arms. The rate of metastatic progression was twice as high in the AM group but was still very low (<5%). Similar results were obtained for disease progression.

The second part of the trial involved validated patient reported outcome measures. These were assessed before diagnosis, at 6 and 12 months after randomization and annually thereafter. General QoL was similar for the 3 treatment arms. Urinary incontinence rates were initially higher for RP patients but by the end of the follow-up period it was identical to the other 2 arms. Identical results were obtained for erectile function. Regarding bowel function, it was not surprising that patients in radiation arm had initial higher rates of bowel complaints that approached baseline by the end of the follow-up period but did not reach identical levels to the other 2 groups. Finally, depression and anxiety were identical between the treatment arms.
This result is surprising when considering that the most common reason for receiving active treatment in the AM arm was anxiety.

It was concluded that CSS and OS are identical in the AM and radical treatment arms, progression and metastases rates were higher in the AM arm. On the other hand, staying on AM avoided treatment side effects, at least in the initial period.

Presented By: James Catto

Written By: Miki Haifler, MD, M.Sc., Society of Urologic Oncology Fellow, Fox Chase Cancer Center

17th Annual Meeting of the Society of Urologic Oncology - November 30 -December 2, 2016 – San Antonio, Texas USA
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