Gallium-68 PSMA-11 PET Imaging 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: NCT03353740
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ga-68 labeled PSMA-11 PET Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Drug: Ga-68 labeled PSMA-11 PET
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Other Names:
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC
  • Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC
  • Ga-68 labeled HBED-CC PSMA

Primary Outcome Measures :
  1. Sensitivity on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. [ Time Frame: 12 months ]
    Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.

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

Inclusion Criteria

  • Histopathologically proven prostate adenocarcinoma.
  • Rising PSA (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    • Post radical prostatectomy (RP) - AUA recommendation for biochemical recurrence after radical prostatectomy

      • PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
    • Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

      • Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Karnofsky performance status of > 50 (or ECOG/WHO equivalent).
  • Age > 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

  • Unable to lie flat, still or tolerate a PET scan.
  • Concomitant investigational therapy.
  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

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): NCT03353740

United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Raven Smith    415-353-9448   
Principal Investigator: Thomas Hope, MD         
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Thomans Hope, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT03353740     History of Changes
Other Study ID Numbers: 175518
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Edetic Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action