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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSt. Antonius Hospital

About this trial

The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,.

The main questions it aims to answer are:

* Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed? * Does it reduce unnecessary biopsies and overtreatment?

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • PSA and MRI-monitoring

Treatment groups

503 Participants
are divided into 1 treatment group

Sponsors and collaborators