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Update on Prostatectomy Versus Observation Trials

by Gerald L. Andriole, Jr., MD | Jul 2018

Gerald L. Andriole Jr., MD, presented “Update on Prostatectomy Versus Observation Trials” during the 23rd Annual Southwest Prostate Cancer Update on April 15, 2018 in Scottsdale, Arizona

How to cite: Andriole, Gerald L. “Update on Prostatectomy Versus Observation Trials” April 15, 2018. Accessed [date today]. https://grandroundsinurology.com/Update-on-Prostatectomy-Versus-Observation-Trials/

Update on Prostatectomy Versus Observation Trials – Summary:

Gerald L. Andriole Jr., MD, who served on the cause of death ascertainment committee for the Prostate Intervention Versus Observation Trials (PIVOT), discusses PIVOT and criticisms to the trial design. He then analyzes similar trials testing definitive versus non-definitive treatment in low-risk disease.

PIVOT Objective and Results

In 2012, The New England Journal of Medicine published the randomized trial PIVOT. It tested whether or not the intent to treat with radical prostatectomy (RP) in men with screen-detected, clinically localized prostate cancer reduces mortality compared to observation. They published a follow-up article in 2017. Notably, the inclusion criteria required patients to have a PSA value of less than 50 ng per milliliter. Also, patients had to have had a predicted life expectancy of 10 years or longer.

Results showed that surgery did not reduce mortality in men with low PSA or low-risk prostate cancer. This observation, in conjunction with other trials, has increased urologists’ and patients’ awareness and acceptance of surveillance. On the other hand, PIVOT results support that surgery is likely beneficial for men with higher PSA and/or intermediate risk disease.

Criticisms of PIVOT

However, the PIVOT trial had many limitations. Patient volunteers most likely had a higher severity of disease than in most RP series. Sextant biopsy determined the diagnoses for most of the patients in this trial, so some men considered to have low-risk disease likely harbored undiagnosed Gleason 4 pattern elements.

Furthermore, the trial design required 2000 patients, but only included 731 patients. Therefore, this trial was too underpowered to result in quality data. Issues with crossover and noncompliance may have diluted the trial results, as well.

Additional Prostatectomy versus Observation Studies

Additional randomized trials comparing definitive versus non-definitive treatment in early prostate cancer include The Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), the Prostate Testing for Cancer and Treatment (ProtecT) trial, and the Long-Term Follow-Up of a Large Active Surveillance Cohort of Patients With Prostate Cancer (led by Laurence Klotz, MD, FRCSC). The graphs below compare baseline characteristics and results of these three studies and PIVOT.

About The Author

Gerald L. Andriole, Jr., MD

Gerald L. Andriole, Jr., MD, is the global Chief Medical Officer at Prostatype Genomics. He previously was Professor and Director of Urology in the National Capital Region at the Brady Urologic Institute at Johns Hopkins University. He also formerly served as the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Barnes-Jewish Hospital, the Siteman Cancer Center, and Washington University School of Medicine in St. Louis, Missouri. Dr. Andriole received his medical degree from Jefferson Medical College in Philadelphia, Pennsylvania. He trained in surgery at Strong Memorial Hospital and the University of Rochester and completed his Urology Residency at Brigham and Women’s Hospital and Harvard Medical School. Subsequently, he was a Fellow in Urologic Oncology at the National Cancer Institute in Bethesda, Maryland. Dr. Andriole has over 40 years of consistent contributions in the areas of prostate cancer screening and prevention research as well as BPH. He has contributed over 450 peer-reviewed publications. He chaired the Prostate Committee of NCI’s PLCO Cancer Screening Trial, the Steering Committee of the international REDUCE Chemoprevention Trial and the Prostate Committee of the SUO Clinical Trials Consortium. He is a member of the American Urological Association, the Academy of Master Surgical Educators of the American College of Surgeons, the American Surgical Association, the American Association of Genitourinary Surgeons, and the Clinical Society of Genitourinary Surgeons, among other societies. He has received the Outstanding Achievement Award from the Urologic Oncology Branch of NCI, the Distinguished Clinician Award from Washington University, the Alumni Award from Jefferson Medical College and the Williams Award for Prostate Cancer Research Excellence from the AUA Urology Care Foundation, among others.

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