A 2-year prospective evaluation of the Prostate Health Index in guiding biopsy decisions in a large cohort.

To prospectively evaluate how the Prostate Health Index (PHI) impacts on clinical decision in a real-life setting for men with a prostate-specific antigen (PSA) level between 4 and 10 ng/mL and normal digital rectal examination.

Since 2016, the PHI has been available at no cost to eligible men in all Hong Kong public hospitals. All eligible patients who received PHI testing in all public Urology units (n = 16) in Hong Kong between May 2016 and August 2017 were prospectively included and followed up. All included men had a PHI test, with its result and implications explained; the subsequent follow-up plan was then decided via shared decision-making with urologists. Patients were followed up for 2 years, with outcomes including prostate biopsy rates and biopsy findings analysed in relation to the initial PHI measurements.

A total of 2828 patients were followed up for 2 years. The majority (82%) had PHI results in the lower risk range (score <35). Knowing the PHI findings, 83% of the patients with elevated PSA decided not to undergo biopsy. In all, 11% and 45% opted for biopsy in the PHI score <35 and ≥35 groups, respectively. The initial detection rate of International Society of Urological Pathology (ISUP) Grade Group (GG) ≥2 cancer was higher in the PHI score ≥35 group (23%) than in the PHI score <35 group (7.9%). Amongst patients with no initial positive biopsy findings, the subsequent positive biopsy rate for ISUP GG ≥2 cancer was higher in the PHI score ≥35 group (34%) than the PHI score <35 group (13%) with a median follow-up of 2.4 years.

In a real-life setting, with the PHI incorporated into the routine clinical pathway, 83% of the patients with elevated PSA level decided not to undergo prostate biopsy. The PHI pathway also improved the high-grade prostate cancer detection rate when compared to PSA-driven strategies. Higher baseline PHI predicted subsequent biopsy outcome at 2 years. The PHI can serve as a tool to individualise biopsy decisions and frequency of follow-up visits.

BJU international. 2024 Jul 04 [Epub ahead of print]

Peter Ka-Fung Chiu, Alex Qinyang Liu, Sui-Yan Lau, Jeremy Yuen-Chun Teoh, Chi-Chun Ho, Chi-Hang Yee, See-Ming Hou, Chi-Kwok Chan, Wai-Lun Tang, Chris H Bangma, Peggy Sau-Kwan Chu, Wing-Tat Poon, Chi-Fai Ng, Monique J Roobol

Department of Surgery, SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China., Department of Pathology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, China., Department of Urology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands., Division of Urology, Department of Surgery, Tuen Mun Hospital, Hong Kong, China.