Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Sponsor
University of Michigan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03396874
Collaborator
(none)
1,335
1
1
53.7
24.9

Study Details

Study Description

Brief Summary

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Detailed Description

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.

Study Design

Study Type:
Interventional
Actual Enrollment :
1335 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Actual Study Start Date :
Feb 9, 2018
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Positive predictive value (PPV) of 68Ga PSMA PET/CT for detection of prostate cancer on a per-patient basis. [Up to 12 months after 68Ga-PSMA scan]

      The positive predictive value (PPV) of 68Ga PSMA PET/CT for detecting prostate cancer on a per-patient basis will be confirmed by histopathology.

    Secondary Outcome Measures

    1. Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA PET/CT for detection of tumor location. [Up to 12 months after 68Ga-PSMA scan]

      The sensitivity and PPV of 68Ga-PSMA PET/CT will be determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and histopathology/biopsy where available.

    2. Adverse events of 68Ga-PSMA administration [24 hours post injection]

      Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Histopathological proven prostate adenocarcinoma.

    2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    3. Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

    4. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.

    5. Karnofsky performance status of ≥ 50.

    6. Age ≥ 18.

    7. Ability to understand a written informed consent document, and the willingness to sign it.

    Exclusion Criteria:
    1. Current investigational therapy for prostate cancer.

    2. Unable to lie flat, still or tolerate a PET/CT scan.

    3. Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.

    4. Prisoner.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Morand R Piert, M.D., University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Morand Piert, MD, Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT03396874
    Other Study ID Numbers:
    • HUM125841
    First Posted:
    Jan 11, 2018
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 11, 2022