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?
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
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)
Single group
PSA and MRI-monitoring
Other interventionMen with PI-RADS 3 or 4 lesions and a PSA density ≤ 0.15 ng/mL² are actively monitored with PSA testing every six months and MRI annually, instead of undergoing immediate prostate biopsy.
Proportion clinically significant prostate cancer missed during follow up
Detection percentage of International Society of Urological Pathology Grade Group (ISUP GG)≥ 2 prostate cancer (= clinically significant prostate cancer) during 48 months of follow up compared with the percentage of total ISUP GG≥ 2 during the study, including any findings from end of study biopsies. ISUP grade groups range from 1 to 5, and a ISUP GG≥ 2 is defined as clinically significant prostate cancer.
Number of clinically insignificant prostate cancer detected
Detection of clinically insignificant prostate cancer (International Society of Urological Pathology Grade Group (ISUP GG) 1) during the 48 months of follow up compared to the total ISUP GG 1 including end of study biopsies.
Number of negative biopsies
Number of participants with negative biopsy results during the study including findings from the end of study biopsies.
Grade shifts
Progression rates of intermediate- to high-risk group during monitoring, rates of downgrading from intermediate risk to low risk
Detection of very high risk prostate cancer
Detection of very high risk prostate cancer (ISUP GG ≥ 3) during the study, including end of study biopsies.
Health-related quality of life (EPIC-26 score)
Change in health-related quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire with subscales ranging from 0 to 100. Higher scores indicate better function and less symptom burden. Although the diagnosis of prostate cancer is not confirmed, this is the best validated and suitable questionnaire. Participants will be asked to fill in the questionnaire once a year.
Estimated average cost per patient during 48-month follow-up
Mean cost per participant over 48 months, including diagnostics (e.g. MRI, biopsies), consultations, and treatments, based on predefined unit costs and healthcare utilization.
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