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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: [18F]PSMA-PET; Device: MRI sequences optimized for prostate cancer examinations

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Camilla Thellenberg Karlsson, MD, PhD; Phone Number: +46907850000; Email: camilla.thellenberg@umu.se
• Study Contact Backup: Name: Tufve Nyholm, PhD; Phone Number: +46907850000; Email: tufve.nyholm@umu.se

Study Locations

• Sweden
  • Malmö, Sweden
    • Recruiting
    • Region Skane
    • Contact: Adalsteinn Gunnlaugsson, MD, PhD; Phone Number: +46 46 17 10 00; Email: adalsteinn.gunnlaugsson@skane.se
  • Umeå, Sweden
    • Recruiting
    • Region Västerbotten
    • Contact: Camilla Thellenberg Karlsson; Phone Number: +46 907850000; Email: camilla.thellenberg@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI; One-time pre-surgical imaging using [18F]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)	Drug: [18F]PSMA-PET; Pre-surgical imaging using [18F]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.; Device: MRI sequences optimized for prostate cancer examinations; T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions	Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.	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

Collaborators and Investigators

• Sponsor: Region Västerbotten
• Collaborators: Lund University; Umeå University; Region Skane
• Investigators: Principal Investigator: Camilla Thellenberg Karlsson, MD, PhD, Region Västerbotten

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PAMP2; CIV-23-04-042756 (Other Identifier: Swedish Medical Products Agency); 2022-501892-14-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Trial data that are possible to de-identify (anonymize) will be made available to other research groups through an open repository such as https://zenodo.org or equivalent. Shared data will not be directly traceable to an individual participant.
• IPD Sharing Time Frame: Study protocol and anonymized data will be made available after study closure.
• IPD Sharing Access Criteria: Study protocol will be publicly available. Anonymized data will be accessible by request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No