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Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT03689582
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-PSMA Phase 2

Detailed Description:

In this study, two different imaging tests are being compared: a) 68Ga-PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) and b) Magnetic Resonance Imaging (MRI) of the prostate gland. Participants already have received the MRI, and this test resulted either suspicious or definitive for prostate cancer. Both tests (MRI and 68Ga-PSMA PET/CT) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test.

Another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. If imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future.

To investigate these questions, participants are asked to undergo a 68Ga-PSMA PET/CT before a planned prostate biopsy procedure. After the biopsy procedure is performed, investigators will compare the imaging results from 68Ga-PSMA with those from the MRI and determine which test is more accurate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: 68Ga-PSMA
PET/CT imaging
Drug: 68Ga-PSMA

PET/CT imaging with 68Ga-PSMA:

68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Other Names:
  • Gallium-68 PSMA-HBED-CC
  • Gallium-68 PSMA-11




Primary Outcome Measures :
  1. Sensitivity and specificity of multiparametric MRI (mpMRI) in combination with 68Ga-PSMA Positron Emission Tomography/Computed Tomography (PET/CT) (i.e., fusion PET/MRI) for the detection of primary Gleason score ≥ 3+4 prostate cancer. [ Time Frame: Up to ~4 weeks (after planned, standard-of-care biopsy). ]
    Reference standard will be pathology-defined as targeted plus standard prostate biopsy, and prostatectomy, when available. Investigators will employ mixed effects logistic regression model to estimate the positive likelihood ratio (LR) of the combination of 68Ga-PSMA-guided plus mpMRI- guided biopsy (fusion PET/MRI) for the detection of primary Gleason ≥ 3+4 cancer compared to mpMRI-guided biopsy (using Prostate Imaging - Reporting and Data System [PI-RADS] version 2) alone.


Secondary Outcome Measures :
  1. Adverse events of 68Ga-PSMA administration [ Time Frame: 24 hours post injection ]
    Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
  • Treating physician has already indicated a need for a prostate biopsy procedure.
  • Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

  • Prostate biopsy within 12 weeks before enrollment
  • Acute prostatitis within the last 6 months
  • Current non-urologic bacterial infection requiring active treatment with antibiotics
  • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  • Body weight greater than 350 lbs (158 Kg)
  • Inability or unwillingness to receive a prostate biopsy procedure
  • Unable to lie flat, still, or tolerate a PET/CT scan
  • Unable to provide own consent
  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

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 ClinicalTrials.gov identifier (NCT number): NCT03689582


Contacts
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Contact: Morand R Piert, M.D. 734-763-5272 mpiert@med.umich.edu

Locations
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United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Pool    734-615-7391    jampool@med.umich.edu   
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Morand R Piert, M.D. University of Michigan
Publications:
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03689582    
Other Study ID Numbers: UMCC 2018.072
HUM00146602 ( Other Identifier: University of Michigan )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Available as requested. Data will be archived indefinitely for research purposes.
Access Criteria: Individuals seeking use of these data should contact the study chair.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action