RecruitingPhase 3NCT06565247

Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation


Sponsor

Region Västerbotten

Enrollment

60 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether combining a PSMA-PET scan (a highly sensitive nuclear imaging test for prostate cancer) with a multiparametric MRI (a detailed MRI specifically for prostate) is better than either test alone at detecting if prostate cancer has spread beyond the prostate before surgery in men with high-risk disease. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer that is planned to be treated with surgical removal of the prostate - Your cancer is classified as high-risk (T3 stage, Gleason score ≥8, or PSA between 20–49) - You have already had or are scheduled for a PSMA-PET scan as part of your standard care **You may NOT be eligible if...** - You have metal implants that are not safe for MRI, or you have claustrophobia - You are already on hormone therapy (anti-testosterone treatment) - Your cancer has already spread to bones, organs, or lymph nodes outside the pelvis - You have had another cancer diagnosis (with limited exceptions) - Your kidney function is significantly impaired - You have tinnitus or severe hearing loss Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]PSMA-PET

Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.

DEVICEMRI sequences optimized for prostate cancer examinations

T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital


Locations(2)

Region Skåne

Malmö, Sweden

Region Västerbotten

Umeå, Sweden

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NCT06565247


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