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

• Sponsor: Irene Burger (Other)
• Overall Status: Completed
• CT.gov ID: NCT03187990
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 53
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: [68Ga]PSMA-11; Drug: [18F]PSMA-1007	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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.
• Actual Study Start Date: Mar 3, 2017
• Actual Primary Completion Date: Aug 3, 2021
• Actual Study Completion Date: Aug 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/MRI before biopsy 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; PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.; Other Names: PSMA PET/MRI ; Drug: [18F]PSMA-1007; 18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.; Other Names: PSMA PET/CT
Experimental: PET/MRI after biopsy 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; PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.; Other Names: PSMA PET/MRI

Outcome Measures

Primary Outcome Measures

1. Rate of positive histopathology for [68Ga]PSMA-11 positive lesions [7 months]

   PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section.

Secondary Outcome Measures

1. Correlation of [68Ga]PSMA-11 with tumor aggressiveness [7 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• Irene Burger

Investigators

• Principal Investigator: Irene A Burger, MD, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Irene Burger, Principal investigator, University of Zurich
• ClinicalTrials.gov Identifier: NCT03187990
• Other Study ID Numbers: KEK-ZH-NR: 2017-00016
• First Posted: Jun 15, 2017
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Irene Burger, Principal investigator, University of Zurich: PSMA PET/MRI; Guided Biopsy; Prostate Cancer
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Sep 2, 2021