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Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

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ClinicalTrials.gov Identifier: NCT03353740
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, 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 its 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: N/A
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 : September 20, 2017
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

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. True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  2. True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  3. True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  4. True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up [ Time Frame: 1 day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.


Secondary Outcome Measures :
  1. Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

  2. PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

  3. PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

  4. PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

  5. True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

  6. True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

  7. True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only [ Time Frame: 1 Day ]
    The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

  8. True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only [ Time Frame: 1 Day ]
    The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

  9. PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy

  10. PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy

  11. PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy

  12. PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only [ Time Frame: 1 Day ]
    Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy

  13. Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value [ Time Frame: 1 Day ]
    Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, >=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up.

  14. Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment [ Time Frame: 1 Day ]
    Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format.

  15. Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) [ Time Frame: 1 Day ]
    Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format.

  16. Percent of Participants With a Change in Clinical Management [ Time Frame: Up to 6 months ]
    Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys.

  17. Rate of Inter-reader Reproducibility for Positivity [ Time Frame: 1 Day ]
    Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers

  18. Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events [ Time Frame: Up to 30 days ]
    All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug.



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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

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

    • Post radical prostatectomy (RP) - American Urological Association (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 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

  • 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 ClinicalTrials.gov identifier (NCT number): NCT03353740


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Thomas Hope
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Hope, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03353740    
Other Study ID Numbers: 175518
NCI-2018-00040 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: November 27, 2017    Key Record Dates
Results First Posted: October 21, 2021
Last Update Posted: October 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified datasets were made available to collaborating researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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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