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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Antoni van Leeuwenhoek Hospital
NOT_YET_RECRUITING
Amsterdam
Andros Clinics
RECRUITING
Arnhem
St Antonius Hospital
RECRUITING
Nieuwegein
Canisius Wilhelmina Hospital
RECRUITING
Nijmegen
Radboud University Medical Centre
RECRUITING
Nijmegen
Maasstad Hospital
NOT_YET_RECRUITING
Rotterdam
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2031-01
Participants
Target number of participants: 503
Treatments
Experimental: Study arm
Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually.
Related Therapeutic Areas
Sponsors
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov