Using repeated MRI and PSA to reduce overdiagnosis and avoid unnecessary prostate biopsies

Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

This approach tests whether regular PSA checks and repeat MRI for men with moderate prostate cancer risk can safely delay biopsies and reduce unnecessary procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 503 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: St. Antonius Hospital (Academic / other)
• Locations: 7 sites (Emmen, Drenthe and 6 other locations)
• Trial ID: NCT07180381 on ClinicalTrials.gov

What this trial studies

Men with intermediate-risk findings on MRI (PI-RADS 3 or PI-RADS 4 with PSA density ≤0.15) and PSA <20 ng/mL are followed with scheduled PSA testing and repeat MRI instead of immediate biopsy. Participants are followed for up to four years to see whether clinically significant cancers are detected in time while avoiding unnecessary biopsies. The main safety outcome is how often clinically significant cancers are missed or diagnosed late, and secondary outcomes include the number of biopsies avoided and measures of overtreatment. Men with prior prostate biopsy or cancer, those on hormonal therapy, with known high-risk germline mutations, or unable to undergo MRI are excluded.

Who should consider this trial

Good fit: Men with life expectancy over 10 years, initial PSA under 20 ng/mL, intermediate MRI findings (PI-RADS 3 or PI-RADS 4 with PSAD ≤0.15), no prior prostate biopsy or cancer, and able to undergo repeated MRI are ideal candidates.

Not a fit: Men with higher-risk features (for example PI-RADS 5 or PSAD >0.15), prior prostate cancer or biopsy, known pathogenic germline mutations (e.g., BRCA1/2), those on hormonal therapy, or those who cannot have MRIs are unlikely to benefit from this monitoring approach.

Why it matters

Potential benefit: If successful, this approach could spare many men unnecessary biopsies and reduce overdiagnosis and overtreatment while still catching cancers that need treatment.

How similar studies have performed: MRI-guided and active surveillance approaches for low-risk prostate cancer have reduced biopsies and overtreatment, but using PSA plus MRI monitoring specifically in this intermediate-risk group is less well established.

Eligibility criteria

Inclusion Criteria:

* Life expectancy \> 10 years
* initial PSA \< 20 ng/ml
* No signs of extracapsular disease on digital rectal examination
* Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\< 0.15
* Mentally competent and able to comprehend the potential benefits and burdens of the study
* Willing to undergo the follow-up protocol for a maximum of four years
* written and signed informed consent

Exclusion Criteria:

* Men who have previously undergone a prostate biopsy
* Men who have a prior PCa diagnosis
* using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors
* Proven germline mutation for PCa (for example: BRCA1; BRCA2)
* Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.
* severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)

Where this trial is running

Emmen, Drenthe and 6 other locations

• Treant — Emmen, Drenthe, Netherlands (Recruiting)
• Andros Clinics — Arnhem, Gelderland, Netherlands (Recruiting)
• Radboud University Medical Centre — Nijmegen, Gelderland, Netherlands (Recruiting)
• Canisius Wilhelmina Hospital — Nijmegen, Gelderland, Netherlands (Recruiting)
• Antoni van Leeuwenhoek Hospital — Amsterdam, North Holland, Netherlands (Recruiting)
• Maasstad Hospital — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
• St Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)

Conditions Prostate Cancer