Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
NCT ID: NCT07180381
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
503 participants
INTERVENTIONAL
2025-05-14
2031-01-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study arm
Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually.
PSA and MRI-monitoring
Men 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.
Interventions
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PSA and MRI-monitoring
Men 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
MALE
No
Sponsors
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St. Antonius Hospital
OTHER
Responsible Party
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Harm H.E. Van Melick
MD PhD
Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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NL-005445
Identifier Type: -
Identifier Source: org_study_id
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