Update on Prostatectomy Versus Observation Trials
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, is Chief Medical Officer of Prostatype
Genomics. He retired in June 2023 from Johns Hopkins University
where he was Professor and Director of Urology in the National Capital
Region. Previously, he had been the Royce Distinguished Professor and
Chief of Urologic Surgery at Washington University in St. Louis for
over 20 years.
Dr. Andriole participated in the 5-year accelerated medical program at
Penn State University and Jefferson Medical College, Philadelphia, PA.
He trained in surgery at Strong Memorial Hospital, University of
Rochester, NY and completed urology residency at Brigham and
Women’s Hospital, Harvard Medical School, Boston, MA. He served a
fellowship in Urologic Oncology at the National Cancer Institute of NIH
in Bethesda, Maryland prior to joining the faculty at Washington
University.
Dr. Andriole has significant expertise in prostate cancer screening and
prevention. He was continuously funded by NIH from 1993 and has
contributed over 450 peer-reviewed publications (H-index of 110). He
chaired the Prostate Committee of NCI’s PLCO Cancer Screening Trial
and led the international REDUCE Prostate Cancer Chemoprevention
Trial. He also chaired the Prostate Committee of the Society of Urologic
Oncology Clinical Trials Consortium.
Dr. Andriole is an elected member of the American Surgical
Association, American Association of Genitourinary Surgeons, and the
Clinical Society of Genitourinary Surgeons. He received the
Outstanding Achievement Award from the Urologic Oncology Branch
of NCI, the Distinguished Clinician Award from Washington University,
the Distinguished Alumni Award from Jefferson Medical College and
the Williams Award for Prostate Cancer Research Excellence from the
American Urologic Association Urology Care Foundation.
