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Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (PSMA BCR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02918357
First Posted: September 28, 2016
Last Update Posted: November 20, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco
  Purpose
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 Intervention Phase
Prostate Cancer Drug: Ga-68 labeled PSMA-11 PET Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Resource links provided by NLM:


Further study details as provided by Thomas Hope, University of California, San Francisco:

Primary Outcome Measures:
  • Sensitivity of PSMA PET for the detection of metastases a per-patient and per-region-basis confirmed by histopathology/biopsy. [ Time Frame: one month ]
    Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.

  • Positive predictive value of PSMA PET for the detection of metastases a per-patient and per-region-basis confirmed by histopathology/biopsy. [ Time Frame: one month ]
    Point estimate of the positive predictive value will be calculated with the corresponding 95% confidence interval.


Enrollment: 375
Actual Study Start Date: October 2016
Study Completion Date: October 2017
Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
  Eligibility

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

Inclusion Criteria:

  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    • Post radical prostatectomy (RP) - AUA recommendation

      • PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
      • Confirmatory persistent PSA greater than 0.2 ng/mL
    • Post-radiation therapy -ASTRO-Phoenix consensus definition

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

Exclusion Criteria:

  • Investigational therapy for prostate cancer.
  • Unable to lie flat, still or tolerate a PET scan.
  • Prior history of any other malignancy within the last 2 years, 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).
  Contacts and Locations
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): NCT02918357


Locations
United States, California
UCSF Imaging Center at China Basin
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
  More Information

Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Imaging, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02918357     History of Changes
Other Study ID Numbers: 165510
First Submitted: September 27, 2016
First Posted: September 28, 2016
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes