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RECRUITINGPHASE3

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

NCT06565247•Region Västerbotten

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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

Locations (2)

Region Skåne

Malmo, Sweden

Region Västerbotten

Umeå, Sweden

Key Dates

Start Date

October 14, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2031

Last Updated

March 4, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

[18F]PSMA-PET

DRUG

MRI sequences optimized for prostate cancer examinations

DEVICE

Contacts

Camilla Thellenberg Karlsson, MD, PhD

CONTACT

+46907850000 camilla.thellenberg@umu.se

Tufve Nyholm, PhD

CONTACT

+46907850000 tufve.nyholm@umu.se

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC