Evaluation of [68Ga]PSMA PET/MRI in intermediate and high risk prostate cancer – a comparison with mpMRI, [11C]ACE PET/CT and histopathological validatio

Phase 1

Conditions: Medium and high risk prostate cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2015-005046-55-SE

Lead Sponsor: meå University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

-Histologically confirmed intermediate/high risk prostate cancer
- =2 months since last biopsy of the prostate
- Gleason 3+4 or higher
-Written informed consent
-> 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Non MR-safe implants or other contraindication to MRI,PET or CT
-WHO PS>1
-TUR-P within 6 months
-Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
-Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our hypothesis is that [68Ga]PSMA PET/MRI imaging will provide a sensitive diagnostic tool of primary, secondary (metastasis) and recurrent PC tumours as well as allowing for accurate staging of PC prior to treatment. The goal is to determine if [68Ga]PSMA is safe and not associated with any side-effects and other adverse events. The goal is also to test the hypothesis that [68Ga]PSMA PET/MRI provides improved staging and grading of prostate cancer compared to [11C]ACE PET/CT and standalone mpMRI.<br>;Secondary Objective: Not applicable;Primary end point(s): •To evaluate the safety and performance of [68Ga]PSMA PET/MRI when used in diagnosis and treatment planning applications of prostate cancer.<br>•If [68Ga]PSMA PET/MRI will correctly detect/define 80% of index tumor lesions, with a diameter of at least 7 (5) mm.<br>;Timepoint(s) of evaluation of this end point: Not more than 2 years after LVLS

Secondary Outcome Measures