- Design
- Prospective multicentre single-arm trial
- Population
- 230 biopsy-naive men with suspected prostate cancer
- Primary outcome
- Adverse events and patient-reported outcomes to 6 months
- Effect
- 94.8% symptom-free after biopsy; QoL change attributed to diagnosis 49.6% vs biopsy 1.7%
The prospective multicentre DEPROMP trial performed systematic, MRI-targeted and PSMA PET/CT-targeted transrectal biopsy in 230 biopsy-naive men with suspected prostate cancer, and followed adverse events and patient-reported outcomes for six months.
After biopsy, 94.8% had no symptoms and 87.4% were symptom-free at six months; most adverse events were Clavien-Dindo grade 1 to 2 and infections were rare. At six months, 42.6% reported unchanged and 22.1% improved quality of life, while 29.5% reported deterioration. Patients attributed change to the cancer diagnosis (49.6%) far more than to biopsy complications (1.7%). A cancer diagnosis was strongly associated with worse quality of life (OR 12.94).
Adding PSMA targets to an MRI pathway does not appear to add procedural burden. The larger message is psychological: the diagnosis, not the needle, is what patients carry. The study had no comparison arm and used transrectal access, so infection rates may differ with transperineal biopsy.
- Reassure men that combined MRI- and PSMA-targeted biopsy caused mostly minor, short-lived complications in this trial.
- Plan psychological support at diagnosis; quality-of-life decline was tied to the cancer, not the biopsy.
- Follow local protocols on transrectal versus transperineal access; this trial used transrectal biopsy.
- Record adverse events systematically to benchmark your own biopsy pathway.
Why it matters
It shifts attention from biopsy complications to the psychological impact of a cancer diagnosis.
Don't overread it
Single-arm with no comparison pathway; transrectal access limits comparison with transperineal practice.
The statistics, in plain English
An odds ratio of 12.94 means the odds of reporting worse quality of life were about 13 times higher after a cancer diagnosis. The abstract does not give a confidence interval, and the number of men with deterioration is modest.
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