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

Phase 3

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: [18F]PSMA-PET; Device: MRI sequences optimized for prostate cancer examinations

• Registration Number: NCT06565247
• Lead Sponsor: Region Västerbotten

Brief 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.

Detailed Description

Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.

High-risk prostate cancer patients referred for radical prostatectomy.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-10-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy

2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.

3. ≥4 weeks since last biopsy of the prostate

4. One or more of the following criteria

   1. cT3, or high suspicion of extra prostatic growth on mpMRI
   2. Gleason score ≥8
   3. PSA 20-49 ng/ml

5. >18 years

6. Given a written consent to participate in the trial

Exclusion Criteria

1. Non-MR-safe implants or another contraindication to MRI or PET
2. Claustrophobia
3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
4. WHO PS >1
5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
6. TUR-P within 6 months
7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
8. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
9. Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
10. Tinnitus or severe hearing loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI	[18F]PSMA-PET	One-time pre-surgical imaging using \[18F\]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI	MRI sequences optimized for prostate cancer examinations	One-time pre-surgical imaging using \[18F\]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)

Primary Outcome Measures

Name	Time	Method
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions	Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology	Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.

Trial Locations

Locations (2)

Region Skåne; 🇸🇪 Malmö, Sweden

Region Västerbotten; 🇸🇪 Umeå, Sweden