Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Recruiting · NCT07180381 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Antonius Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PSA and MRI-monitoring
What this trial is about
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?
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
7 locations listed.
- Treant - Emmen, Drenthe, Netherlands
- Andros Clinics - Arnhem, Gelderland, Netherlands
- Radboud University Medical Centre - Nijmegen, Gelderland, Netherlands
- Canisius Wilhelmina Hospital - Nijmegen, Gelderland, Netherlands
- Antoni van Leeuwenhoek Hospital - Amsterdam, North Holland, Netherlands
- Maasstad Hospital - Rotterdam, South Holland, Netherlands
- St Antonius Hospital - Nieuwegein, Utrecht, Netherlands