Prostate Cancer Clinical Trials

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

Status: Recruiting
Location: See all (7) 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
RECRUITING
Amsterdam
Andros Clinics
RECRUITING
Arnhem
Treant
RECRUITING
Emmen
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