Multimodal Biopsy Combo Shows Low Morbidity in Suspected Prostate Cancer

Combined systematic, MRI-targeted, and prostate-specific membrane antigen (PSMA) PET/CT–targeted transrectal biopsy was associated with low morbidity and favorable patient-reported outcomes (PROs) in biopsy-naive men with suspected prostate cancer. The results came from a secondary analysis of the prospective, multicenter DEPROMP trial published in World Journal of Urology.¹

Immediately after biopsy (t1), 94.8% of patients reported no adverse events (AEs). Urinary retention requiring catheterization occurred in 2.6% of patients and orthostatic symptoms in 1.3%, and no infectious complications were observed. Per the Clavien-Dindo classification, 1.3% of patients had grade 1 events, and 2.6% had grade 2 events.

AEs peaked at the intermediate follow-up visit (t2), when 61.3% of patients reported no AEs. Hematuria lasting more than 2 days was the most common event (23.5%), followed by hematospermia (6.1%) and combined hematuria/hematospermia (4.8%). One patient (0.4%) required hospitalization for hematuria with urinary retention and continuous bladder irrigation. Grade 1 and grade 2 AEs occurred in 34.8% and 1.7% of patients, respectively.

At 6 months (t3), 87.4% of patients were symptom free, with grade 1 events occurring in 7.0% and grade 2 events in 0.4%. Biopsy core number was not associated with AEs at t1 (P = .57), t2 (P = .50), or t3 (P = .24), or across all timepoints (P = .76). AEs were numerically more frequent among patients receiving anticoagulation, but clinically significant complications did not increase.

At 6 months, 42.6% of patients reported unchanged quality of life (QOL), 22.1% reported improvement, and 29.5% reported deterioration. Patients attributed changes to their cancer diagnosis more often than to biopsy-related AEs (49.6% vs 1.7%). In total, 85.7% of patients said they would agree to a repeat biopsy under local anesthesia if clinically indicated.

In the multivariable analysis, a cancer diagnosis was associated with worse QOL (odds ratio [OR], 12.94; 95% CI, 4.45-44.14; P <.001). Surgery (OR, 1.46; 95% CI, 0.64-3.34; P = .366) and AEs (OR, 1.35; 95% CI, 0.70-2.64; P = .369) were not. Willingness to undergo repeat biopsy was significantly lower among patients who experienced AEs (OR, 0.22; 95% CI, 0.07-0.59; P = .005).

“Our findings suggest that integration of MRI- and PSMA-based targeting strategies does not result in a clinically meaningful increase in patient-reported morbidity and is associated with high patient acceptance. These data may support patient counseling and shared decision-making when discussing contemporary image-guided biopsy pathways,” lead author Clarissa Julia Schmidt, of the Department of Urology and Paediatric Urology at University Hospital Bonn in Germany, wrote in the publication with study coinvestigators.¹

The open-label DEPROMP trial enrolled 230 biopsy-naive men with suspected prostate cancer who were eligible for multiparametric MRI, PSMA PET/CT, and transrectal fusion biopsy. In a single session, patients underwent 3 biopsy types: a 12-core systematic biopsy, MRI-ultrasound fusion-targeted biopsy of PI-RADS 3 to 5 lesions, and PSMA PET/CT-ultrasound fusion-guided biopsy of 1 to 3 PSMA-positive regions. Procedures were performed under intravenous ceftriaxone prophylaxis, reflecting the standard of care in 2019. Overall, 137 patients (59.6%) were diagnosed with prostate cancer, and 106 (46.1%) underwent surgery during follow-up.

The parent trial primarily evaluated the diagnostic and therapeutic impact of combined MRI- and PSMA-informed biopsy. End points of this secondary analysis included AEs, assessed at 3 predefined timepoints and graded by Clavien-Dindo classification. They also included PROs at 6 months, including perceived QOL change, its attributed cause, and willingness to undergo repeat biopsy.

The authors acknowledged several limitations:

• All biopsies used the transrectal approach, whereas current guidelines now prefer transperineal biopsy.
• PROs were captured through a single study-specific interview, without a baseline assessment or a validated instrument.
• There was no procedural comparator, so the added morbidity from PSMA-targeted cores could not be isolated.

The authors wrote that their findings extend prior data, including the PRECISION trial (NCT02380027), which showed that MRI-targeted biopsy does not substantially increase morbidity compared with systematic biopsy alone.² Infectious complication rates in DEPROMP were also lower than those reported in previous prospective and population-based studies. The authors suggested this may reflect the prophylactic measures used.

References

1. Schmidt CJ, Reichert T, Gaertner FC, et al. Safety and patient-reported outcomes of multimodal PSMA PET/MRI-guided prostate biopsy: results from the prospective multicenter DEPROMP trial. World J Urol. 2026;44(1):669 doi:10.1007/s00345-026-06767-6
2. Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;378(19):1767-1777. doi:10.1056/NEJMoa1801993