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

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ClinicalTrials.gov Identifier: NCT02918357
Recruitment Status : Completed
First Posted : September 28, 2016
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Study Description
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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 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 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 : September 15, 2016
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation [ Time Frame: 1 month ]
    PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

  2. Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation [ Time Frame: 1 month ]
    PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.


Secondary Outcome Measures :
  1. PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up [ Time Frame: 1 month ]
    PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

  2. PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up [ Time Frame: 1 month ]
    PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

  3. Sensitivity on a Per-patient Basis [ Time Frame: 1 month ]
    Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

  4. Sensitivity on a Per-region Basis [ Time Frame: 1 month ]
    Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

  5. Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value [ Time Frame: 1 month ]
    Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0).

  6. Inter-reader Agreement Per-region [ Time Frame: 1 month ]
    Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).

  7. Percentage of Participants With Change in Clinical Management [ Time Frame: Up to 1 year ]
    Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.

  8. Safety Assessment - Heart Rate [ Time Frame: 1 day ]
    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

  9. Safety Assessment - Blood Pressure [ Time Frame: 1 day ]
    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.


Eligibility Criteria
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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:

  • Histopathological proven prostate adenocarcinoma.

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

    • Post radical prostatectomy (RP) - American Urological Association (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 Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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
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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
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Thomas Hope, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Thomas Hope, University of California, San Francisco:
Study Protocol and Statistical Analysis Plan  [PDF] August 21, 2016
Informed Consent Form  [PDF] October 18, 2017

More Information
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Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Imaging, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02918357    
Other Study ID Numbers: 165510
NCI-2018-00039 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: September 28, 2016    Key Record Dates
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Recurrence
Disease Attributes
Pathologic Processes
Edetic Acid
Chelating Agents
 Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents