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

St. Antonius Hospital

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Other: PSA and MRI-monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT07180381

NL-005445

Details and patient eligibility

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?

Enrollment

503 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)