Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

• Status: Completed
• Trial end date: 2021-08-03
• Target enrollment: 0
• Participant gender: Male

Summary

In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Irene Burger

Criteria

Inclusion Criteria:

1. Previously undiagnosed patients with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), eligible for prostate needle biopsy.

2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer

3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).

4. Written informed consent

5. Age > 30

Exclusion Criteria:

1. Age> 80

2. Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies)

3. Active urinary tract infection or indwelling catheter

4. Prior pelvic irradiation

5. Prior prostatectomy

6. Prior androgen deprivation hormonal therapy

7. Prostate biopsy within 8 weeks prior to study

8. Prior transurethral resection of the prostate (TURP)