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

Irene Burger52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

[68Ga]PSMA-11DRUG

PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.

[18F]PSMA-1007DRUG

18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer 3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B). 4. Written informed consent 5. Age \> 30 Exclusion Criteria: 1. Age\> 80 2. 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) 3. Active urinary tract infection or indwelling catheter 4. Prior pelvic irradiation 5. Prior prostatectomy 6. Prior androgen deprivation hormonal therapy 7. Prostate biopsy within 8 weeks prior to study 8. Prior transurethral resection of the prostate (TURP)

Locations (1)

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 7 months

Secondary Outcomes

Correlation of [68Ga]PSMA-11 with tumor aggressiveness

Correlation of stanadized uptake value (SUV) on \[68Ga\]PSMA-11 with Gleason Score on histopathology.

Time frame: 7 months

Data from ClinicalTrials.gov

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