Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

Study Overview
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Brief Summary
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In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

Detailed Description
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In this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), which are assigned to a MRI guided biopsy. These patients will undergo one additional PET/MRI scan with [68Ga]PSMA within two to three weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B) [68Ga]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both modalities will be labeled as AB. Every suspicious lesion will be targeted with 3 cores. A maximum of 3 targets will be selected per patient. For arm B: PET/MRI results will be correlated with the template biopsy results. The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score from the histology of the core biopsies will serve as standard of truth. After completion of the PET/MR study part - an amendment for PET/CT was submitted to the local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to investigate the use of PET/CT guided biopsy and intraoperative verivication of the target with a gamma counter.

Official Title
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Single-center Study for Biopsy Guidance Using Gallium-68 Labeled Prostate-specific Membrane Antigen (PSMA) PET/MRI in Patients With Elevated PSA Eligible for Prostate Biopsy in Comparison to Multiparametric MRI.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: [68Ga]PSMA-11
* Drug: [18F]PSMA-1007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously undiagnosed patients with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), eligible for prostate needle biopsy. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B). Written informed consent Age > 30 Exclusion Criteria: Age> 80 Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies) Active urinary tract infection or indwelling catheter Prior pelvic irradiation Prior prostatectomy Prior androgen deprivation hormonal therapy Prostate biopsy within 8 weeks prior to study Prior transurethral resection of the prostate (TURP)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/MRI before biopsy<br>Patients with suspected areas on mpMRI will undergo additional [68Ga]PSMA-11 PET/MRI scan with subsequent mpMRI and PET/MRI guided biopsy. | Drug: [68Ga]PSMA-11<br>* PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.<br>* Other names: PSMA PET/MRI;Drug: [18F]PSMA-1007<br>* 18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.<br>* Other names: PSMA PET/CT;|
| Experimental: PET/MRI after biopsy<br>Patients with unclear areas or a negative finding in the mpMRI for MRI guided biopsy but positive biopsy, which will undergo the additional [68Ga]PSMA-11 PET/MRI scan with [68Ga]PSMA. | Drug: [68Ga]PSMA-11<br>* PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.<br>* Other names: PSMA PET/MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of positive histopathology for [68Ga]PSMA-11 positive lesions | PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of [68Ga]PSMA-11 with tumor aggressiveness | Correlation of stanadized uptake value (SUV) on [68Ga]PSMA-11 with Gleason Score on histopathology. | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA PET/MRI, Guided Biopsy, Prostate Cancer