Status:
WITHDRAWN
Evaluation of a Multimodal Strategy for Early Diagnosis of Men at High Genetic Risk of Prostate Cancer
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Prostate Cancer
Eligibility:
MALE
40-70 years
Phase:
NA
Brief Summary
Inherited predisposition to prostate cancer (PC) has been defined by strict clinical criteria or by genetic profile determined by the presence of a deleterious mutation of deoxyribonucleic acid (DNA) ...
Detailed Description
Hereditary prostate cancer (HPC) has been defined by strict clinical criteria and represents 5% of all newly diagnosed prostate cancers (PC). Inherited predisposition to PC is also genetically determi...
Eligibility Criteria
Inclusion
- Unaffected men at high genetic risk of prostate cancer (PC) defined as being a member from a family that meets hereditary PC criteria or by carrying a mutation of a DNA repair gene (BRCA1 / BRCA2 / CDH1 / MLH1 / MSH2 / MSH6 / PALB2 / PTEN / RAD51C / RAD51D / TP53 / ATM / BARD1 / BLM / BRIP1 / CHEK2 / MRE11A / MLH3 / NBN / RAD50 / STK11) or a gene specific to PC (HOXB13 / 8q24-CASC19)
- Aged between 40 and 70 years old
- Written informed consent signed by the participant
- Affiliated to the social security system
Exclusion
- Contraindication for MRI (any foreign metallic bodies: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) etc., metallic intraocular foreign bodies, implantable neurostimulation systems, cochlear implants/ear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the participant has to remove the device. catheters with metallic components (Swan-Ganz catheter), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid , piercing, clostrophobia, contrast agents allergy or any other contraindication to contrast agents and to their excipients)
- Treatment with a drug that changes PSA level such as 5 alpha reductase inhibitors (dutastéride, finasteride),
- Prostatic biopsy during the last 2 years, or other progressive cancer or co-morbidities threatening survival at 10 years
- Participant under tutorship or / guardianship, and incapable to give informed consent
- Participation to another interventional clinical trial
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05333432
Start Date
January 1 2026
End Date
January 1 2026
Last Update
June 25 2025
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