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EAU 2017

EAU 2017: Special session of the Prostate Cancer Prevention Group: ProtecT

London, England (UroToday.com) In this session, Dr. Hamdy presented an update on the results of the prostate testing for cancer and treatment (ProtecT) trial. ProtecT is the largest randomized trial to date comparing active monitoring, surgery, and radiotherapy for PSA-detected localized prostate cancer. The initial screening included 82,429 men 50 to 69 years of age who received a PSA test. The trial spanned from 1999-2009 and finally included 1643 patients from 9 UK centers who agreed to undergo randomization to active monitoring (545 men), surgery (553), or radiotherapy (545). This was an intention to treat analysis and the primary endpoint was 10-year disease specific survival. Secondary outcome measures were all-cause mortality, progression, metastasis and patient-reported outcome measures (PROMs).

Dr. Hamdy elaborated on the definition of active monitoring, explaining it is a type of surveillance program, including only PSA testing, before incorporation of imaging and systematic repeat biopsies. The goal was to avoid treatment when not needed, and allow treatment when deemed necessary. Triggers based largely on PSA changes led to further investigation including: imaging or biopsy or both.

Participating patients were relatively young and most were Caucasian, resulting in limitations of the study regarding its impact of ethnic differences effects on prostate cancer. 77% of the patients had Gleason 6 disease, but further analysis revealed that only 58% of the patients were truly low risk patients. Pathological stage pT3 disease was present in 29% of the patients.

At 10 year follow-up, prostate cancer specific mortality was around 1% and all-cause mortality was 12% in all three arms (10 fold less than initially anticipated). At 3 years and 10 years follow-up, approximately 25% and 50% of patients received definitive treatment (surgery or radiation), respectively. Radical treatment resulted in 50% reduction of metastasis. Interestingly, approximately 80% of men on active monitoring did not demonstrate any clinical progression. A total of 44% of the men on active monitoring avoided treatment. The number needed to treat (NNT) to prevent one patient from developing metastasis from prostate cancer was 27 for radical prostatectomy and 33 for radiation therapy, while the NNT to prevent one man from clinical progression was 9 for both surgery and radiotherapy. In regards to progression, 53% of Gleason 6 progressed, while 81% of those that did not progress were also Gleason 6. All surgically treated patients who had Gleason 6 disease did not progress.

When specifically looking at patient reported outcomes, worsening of urinary and sexual function were reported in all treated patients. Importantly, men in active monitoring also reported a decline in their sexual function (due to age). Bowel related adverse effects were mainly demonstrated in radiated patients. Quality of life parameters were similar among all 3 study arms.

Dr. Hamdy concluded that genomic diversity is our “Achilles Heel” and distinguishing ‘lethal’ from non ‘lethal’ disease baseline in the future will produce a major paradigm shift

Presented by: F.C. Hamdy, Oxford (GB)

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto

Twitter: @GoldbergHanan

at the #EAU17 -March 24-28, 2017- London, England