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Invited Commentary
June 16, 2022

To Treat or Not to Treat Men With Low-risk or Intermediate-risk Prostate Cancer—Weighing the Evidence

Author Affiliations
  • 1Duke University, Durham, North Carolina
  • 2Emory University School of Medicine, Atlanta, Georgia
  • 3Thomas Jefferson University, Philadelphia, Pennsylvania
JAMA Oncol. 2022;8(8):1137-1138. doi:10.1001/jamaoncol.2022.1623

In this issue of JAMA Oncology, Shore et al1 present the results of the ENACT randomized phase 2 clinical trial. Between June 2016 and August 2020, 227 men with prostate cancer were randomized with equal probability to either undergo active surveillance alone (AS) or receive treatment with enzalutamide plus AS. The median age at randomization was 65 years, and 53% of patients had low-risk cancer as determined by the National Comprehensive Cancer Network guidelines.2 Patients in the treatment arm were treated with enzalutamide, 160 mg, for 1 year with an initial follow-up for 1 year and a second year of follow-up for remaining patients in the trial. The primary end point was time to pathological or therapeutic prostate cancer progression. Pathological progression in the study was defined as an increase in primary or secondary Gleason pattern by at least 1 or higher proportion of cancer-positive cores (≥15% increase). Therapeutic progression was considered on primary therapy for prostate cancer whether this was prostatectomy, radiation, focal therapy, or any systemic therapy.

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1 Comment for this article
Additional potential advantage of delaying treatment of prostate cancer
Larry Lee, MD | Retired
The authors of this Invited Commentary have accomplished their goal of analyzing the results of AS versus initial treatment including the advantage of reversable side effects versus permanent treatment related significant effects on quality of life and the difficulty in documenting and quantifying such effects. There is an additional advantage to be considered: the potential of improvements in treatment outcome resulting from delaying definitive therapy thereby taking advantage of ongoing reduction in permanent unwanted treatment effects and further increase in data and technology allowing for increased survival and quality of life. An example case is a now 70 year old male diagnosed with prostate cancer deemed appropriate for AS. Repeat biopsy at two years post diagnosis revealed an increased Gleason's score promoting definitive treatment. During that two year delay the technology and its implementation had improved such that the side effects of the radiation therapy were dramatically reduced. I submit the need to include documenting this category of advantage to delaying definitive treatment in future randomized trials of this type.