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

Prostate Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187990
• Other study ID #: KEK-ZH-NR: 2017-00016
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• [68Ga]PSMA-11
PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.
• [18F]PSMA-1007
18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Irene Burger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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