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

August 27, 2021 updated by: Irene Burger

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of positive histopathology for [68Ga]PSMA-11 positive lesions
Time Frame: 7 months
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
Time Frame: 7 months
Correlation of stanadized uptake value (SUV) on [68Ga]PSMA-11 with Gleason Score on histopathology.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irene Burger

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2017

Primary Completion (ACTUAL)

August 3, 2021

Study Completion (ACTUAL)

August 3, 2021

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (ACTUAL)

June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR: 2017-00016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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