(UroToday.com) The 2026 American Urologic Association (AUA) Annual Meeting was host to a prostate cancer clinical trials-in-progress session. Dr. Clinton Bahler presented BIPASS, an ongoing phase III study of 68Ga-PSMA-11 PET combined with MRI for the detection of prostate cancer.
Prostate cancer is the second most commonly diagnosed cancer in the United States and is traditionally identified through systematic or template-guided biopsy based on clinical or imaging suspicion.1 For patients at higher risk, anatomically directed biopsies are often performed to detect occult disease, but these procedures can introduce anxiety, complications, financial burden, and logistical challenges.2 Emerging evidence suggests that pairing PSMA PET with MRI for targeted biopsy can improve detection of clinically significant prostate cancer, reduce unnecessary procedures, and potentially replace template or saturation biopsy in selected patients.2-4
Supporting data come from several prospective studies. In the PRIMARY trial of 291 biopsy-naïve men, adding 68Ga-PSMA-11 PET/CT to mpMRI increased both negative predictive value and sensitivity for clinically significant cancer by 19% and 14%, respectively. In another cohort of 56 patients with PI-RADS 3 lesions, only 14.3% were found to have clinically significant cancer on biopsy; using a PRIMARY score threshold of four would have avoided biopsy in more than 80 percent of these men.3 Building on these findings, the Phase 3 BIPASS study is evaluating the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI-targeted biopsy with histopathological confirmation as the reference standard.4
The BIPASS study is a single-arm, multicenter, prospective, open-label longitudinal study (NCT07052214) that will enroll 204 men aged 18 or older with clinical suspicion of prostate cancer who have not yet undergone biopsy. Eligible participants must be scheduled for a template biopsy based on an initial MRI performed within three months before enrollment and have PI-RADS 1–4 findings. Key exclusion criteria include prior prostate cancer treatment, a known diagnosis of prostate cancer, or clear metastatic disease on conventional imaging.
All enrolled patients will undergo both 68Ga-PSMA-11 PET and MRI, followed by standard anatomical template biopsy with a minimum of two cores taken from each of six sectors. PSMA and MRI scans will be reviewed independently by three blinded expert readers. MRI- and PSMA-targeted biopsies will also be performed, with two cores taken from each identified lesion. For participants diagnosed with prostate cancer on histopathology, the lesion-to-imaging correlation will be completed, and no additional follow-up will be required.
Patients with negative baseline imaging and negative biopsy will undergo up to six months of follow-up. During this period, investigators may obtain additional imaging or perform targeted or template biopsies at their discretion. Any new clinical, imaging, histologic, genetic, or intervention data collected during follow-up will contribute to the study’s composite standard of truth. The follow-up phase is designed to ensure that individuals initially classified as negative for prostate cancer on both imaging and pathology are accurately characterized.
The co-primary endpoints are the sensitivity and specificity of combined PSMA PET and MRI-targeted biopsy for detecting prostate cancer, benchmarked against histopathology or a composite truth standard.
Lastly, key secondary endpoints include diagnostic performance metrics such as sensitivity, specificity, PPV, NPV, accuracy, and misclassification rates, as well as interobserver variability in PSMA PET interpretation. Dr Sprenkle mentioned that enrollment is now open and ongoing.
Presented by: Clinton Bahler, MD, Associate Professor of Urology, Indiana University, Indianapolis, IN, USA
Written by: Rashid K. Sayyid, MD, MSc, Assistant Professor, Urologic Oncologist, Department of Urology at The University of Arizona and Banner University Medical Center, Tucson, AZ – @rksayyid on X during the American Urological Association (AUA) 2026 Annual Meeting, Washington, DC, Fri, May 15 – Mon, May 18, 2026.
References:
- SEER Cancer Stat Facts: Prostate Cancer. NCI. 2025.
- Bahadori A, Woods J, Yuan L, Emmett L, Yaxley J, Roberts MJ. Biopsy-free radical prostatectomy: a narrative review considering rationale, limitations, and current data. Prostate Int. 2025 Jun;13(2):67-73. doi: 10.1016/j.prnil.2025.03.003. Epub 2025 Mar 18. PMID: 40620872; PMCID: PMC12223532.
- Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28. PMID: 34465492.
- Shi J, Li D, Chen M, Fu Y, Peng S, Zhang Q, Liang J, Lu Q, Lu J, Ai S, Wang F, Qiu X, Guo H. The Value of 68Ga-PSMA PET/MRI for Classifying Patients with PI-RADS 3 Lesions on Multiparametric MRI: A Prospective Single-Center Study. J Nucl Med. 2024 Apr 1;65(4):555-559. doi: 10.2967/jnumed.123.266742. PMID: 38485278.