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

Phase 3

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06565247
• Lead Sponsor: Region Västerbotten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Histologically confirmed high-risk prostate cancer planned to be treated with<br> radical prostatectomy<br><br> 2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate<br> cancer.<br><br> 3. =4 weeks since last biopsy of the prostate<br><br> 4. One or more of the following criteria<br><br> 1. cT3, or high suspicion of extra prostatic growth on mpMRI<br><br> 2. Gleason score =8<br><br> 3. PSA 20-49 ng/ml<br><br> 5. >18 years<br><br> 6. Given a written consent to participate in the trial<br><br>Exclusion Criteria:<br><br> 1. Non-MR-safe implants or another contraindication to MRI or PET<br><br> 2. Claustrophobia<br><br> 3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain<br><br> 4. WHO PS >1<br><br> 5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical<br> or medical castration or anti-androgens)<br><br> 6. TUR-P within 6 months<br><br> 7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the<br> pelvis.<br><br> 8. Patients with previous diagnosis of other malignant disease. Exceptions could be<br> made for basal cell carcinoma of the skin or progression free survival at least 10<br> years after any previous tumour.<br><br> 9. Creatinine clearance < 30ml/min (acc. to<br> http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)<br><br> 10. Tinnitus or severe hearing loss

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions