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Highlighting the NCI’s working group on biochemically recurrent prostate cancer for clinical trial considerations

Jeanny B. Aragon-Ching1,*, Ravi A. Madan2
1 GU Medical Oncology, Inova Schar Cancer Institute, Fairfax, VA, USA
2 Head, Prostate Cancer Clinical Research Section, National Cancer Institute, NIH, Bethesda, MD, USA
* Corresponding Author: Jeanny B. Aragon-Ching. Email: email
(This article belongs to the Special Issue: Prostate Cancer: Biomarkers, Diagnosis and Treatment)

Canadian Journal of Urology https://doi.org/10.32604/cju.2026.082958

Received 26 March 2026; Accepted 03 September 2026; Published online 23 September 2026

Abstract

Biochemically recurrent prostate cancer (BCR) represents a common clinical challenge following definitive local therapy. While traditionally defined by rising prostate-specific antigen (PSA) levels in the absence of metastatic disease on conventional imaging, the advent of prostate-specific membrane antigen (PSMA) PET has reshaped disease detection. PSMA imaging frequently identifies low-volume, subclinical disease not previously classified as metastatic, raising concerns about overtreatment and inappropriate extrapolation from metastatic castration-sensitive prostate cancer (mCSPC) paradigms. A National Cancer Institute Working Group convened in November 2024 to establish a framework for clinical trial development in this evolving landscape. The group proposed the term PSMA-positive BCR to distinguish this largely indolent disease state from mCSPC, emphasized the importance of paired conventional imaging, and highlighted PSA doubling time as a risk stratification tool. Given favorable long-term outcomes and limited symptoms, future trials should prioritize treatment de-escalation, novel endpoints such as treatment-free survival, and improved quality-of-life measures.

Keywords

biochemical recurrence; prostate cancer; prostate-specific membrane antigen (PSMA); Positron emission tomography (PET) scan
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