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

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: NCT03396874
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : February 8, 2021
Information provided by (Responsible Party):
Morand Piert, MD, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Positive predictive value (PPV) of 68Ga PSMA PET/CT for detection of prostate cancer on a per-patient basis. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA PET/CT for detection of tumor location. [ Time Frame: 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Official Title  ICMJE Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer Metastatic
  • Prostate Cancer Recurrent
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 68Ga-PSMA
PET/CT imaging
Intervention: Drug: 68Ga-PSMA
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

    1. 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.
    2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
  3. Karnofsky performance status of ≥ 50.
  4. Age ≥ 18.
  5. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Pool 734-615-7391
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03396874
Other Study ID Numbers  ICMJE HUM125841
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Morand Piert, MD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Morand R Piert, M.D. University of Michigan
PRS Account University of Michigan
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP