Once upon a time—November, 1994 to be exact–a team of researchers wanted to compare the effectiveness of radical prostatectomy (RP) vs. observation for men with localized prostate cancer (PCa). They launched a 7-year enrollment period, accruing 731 patients who would be randomly assigned to either radical prostatectomy (removal of prostate gland) or observation. Their study was named the Prostate Cancer Intervention Versus Observation Trial, commonly called the PIVOT trial.[i]
Patients were ages up to and including 75, with biopsy-proven localized disease. Their PSA was less than 50 ng/ml, they had a life expectancy of at least 10 years, and they were medically fit for surgery. Per study design, they were followed with scheduled visits every 6 months for a minimum of 8 years, up to a maximum 15 years or until death. Follow-ups included PSA tests, with bone scans at 5, 10, and 15 years.
The study evaluated two outcomes:
- The primary outcome was death from any cause, to find out if prostatectomy conferred an overall survival advantage over observation (or vice versa), and
- The secondary outcome was death that was definitely or probably due to PCa or PCa treatment.
Astonishing initial results
The first published results were released in July 2012, sixteen years after the study’s launch:
Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up.[ii]
In other words, mid-term follow-up revealed that going through RP was no guarantee that a man would live longer than if he didn’t have surgery, while RP urinary and sexual risks could impact his lifestyle for months, possibly years—maybe even the rest of his life.
As you might imagine, PIVOT’s outcome was astonishing for many urologists who had long believed that cutting out the prostate gland was significantly life-extending, even though earlier studies prior to the PSA era had similar findings. What gave great importance to PIVOT, however, was the fact that since PSA screening began, this was the first randomized trial to compare RP against observation in terms of mortality. Skeptics lost a reason to cling to their belief about the lifesaving value of RP.
But wait, there’s more…
Since 2012, meanwhile, the team continued to collect data on study participants who were still living, for a total of over 20 years. In June 2020, long-term results (median follow-up for survivors was 18.6 years) were published. As reported, during the 22.1 years since study inception,
“…515 men died; 246 of 346 men (68%) were assigned to surgery versus 269 of 367 (73%) assigned to observation … The restricted mean survival in the surgical group was 13.6 yr versus 12.6 yr in the observation group; a mean [average] of 1 life-year was gained with surgery.”[iii]
The authors noted that differences in survival favored surgery for men who were younger than 65, of white race with better health quality, ≥34% positive prostate biopsy cores and intermediate risk PCa. Put another way, white men with higher risk cancer, but who were otherwise in good health, did gain better survival with RP than they would have if they were observing/monitoring.
Lead author Dr. Timothy J. Wilt commented by email to journalists,
While surgery may have important mortality benefits in men with long life expectancies having clinically detected, intermediate-risk, and possibly high-risk prostate cancer, our results, together with other treatment trials, provide convincing evidence that observation and PSA-based monitoring result in similar long-term mortality with less harm compared with surgery or radiation for men with PSA-detected low-risk prostate cancer and many with intermediate- or high-risk disease.[iv]
Addition PCa management choice
At the Sperling Prostate Center, it is our experience and conviction that for men with low-risk disease and expected longevity of at least 10 years, a program of Active Surveillance (AS) with PSA monitoring as well as multiparametric MRI is safe, effective at detecting any signs of progression toward significant disease, and avoids all risk of surgery’s potential side effects (until such intervention might be needed).
In addition, for men with low-to-intermediate risk PCa who aren’t comfortable going on AS but don’t like the idea of whole gland treatment, our Center offers Focal Laser Ablation. For qualified candidates, this minimalist outpatient treatment destroys the focus of disease with zero-to-low risk of urinary/sexual compromise. Promising research suggests that for many men, no further treatment will ever be needed.
Both AS and Focal Laser Ablation add up to peace of mind and preservation of quality of life—and longevity that can be boosted by integrating healthy diet, exercise, stress management and good social relationships. The data speaks for itself. The PIVOT study supports pivotal PCa management choices.
NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.
[i] Wilt TJ, Brawer MK, Jones KM, Barry MJ et al. Radical prostatectomy versus observation for localized prostate cancer. Randomized Controlled Trial. N Engl J Med. 2012 Jul 19;367(3):203-13. https://www.nejm.org/doi/full/10.1056/nejmoa1113162
[iii] Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Wilt TJ, Vo TN, Langsetmo L, Dahm P et al. Prostate Cancer Intervention Versus Observation Trial (PIVOT). Eur Urol. 2020 Jun;77(6):713-724. https://pubmed.ncbi.nlm.nih.gov/32089359/
[iv] Douglas, David. “Prostatectomy of Mixed Mortality Benefit in Men With Cancer.” Medscape, Mar 11, 2020. https://www.medscape.com/viewarticle/926536