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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorRegion Västerbotten

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed prostate cancer planned to be treated with radical prostatectomy

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

≥4 weeks since last biopsy of the prostate

One or more of the following criteria

Disqualifiers

Non-MR-safe implants or another contraindication to MRI or PET

Claustrophobia

Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain

WHO PS >1

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]PSMA-PET

    Drug

    Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.

  • MRI sequences optimized for prostate cancer examinations

    Device

    T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Västerbotten

Lead sponsor

Umeå University

Collaborator

Region Skane

Collaborator

Lund University

Collaborator

Source ClinicalTrials.gov
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