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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03187990
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
Irene Burger, University of Zurich

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 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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.
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 : March 3, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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 Name: PSMA PET/MRI

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 Name: PSMA PET/MRI

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03187990

Contact: Irene A Burger, MD +41 44 255 11 11

University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Irene A Burger, MD    +41 44 255 11 11   
Sponsors and Collaborators
Irene Burger
Principal Investigator: Irene A Burger, MD UniversitaetsSpital Zuerich

Responsible Party: Irene Burger, Principal investigator, University of Zurich Identifier: NCT03187990     History of Changes
Other Study ID Numbers: KEK-ZH-NR: 2017-00016
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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, University of Zurich:
Guided Biopsy
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases