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68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

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ClinicalTrials.gov Identifier: NCT02673151
Recruitment Status : Suspended (logistics)
First Posted : February 3, 2016
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Brief Summary:
The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma PSA Failure Recurrent Prostate Carcinoma Procedure: Computed Tomography Drug: Gallium Ga 68-labeled PSMA-11 Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography Phase 2 Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga PSMA 11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring Adverse Events.Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive gallium Ga 68-labeled PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50-100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same .
Procedure: Computed Tomography
Undergo 68Ga-PSMA PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • HBED CC PSMA
  • DFKZ 11
  • The "Heidelberg compound"

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Positron Emission Tomography
Undergo 68Ga-PSMA PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Confirmation of Prostate Cancer Recurrence [ Time Frame: 1 year ]
    Prostate cancer patients with suspected prostate cancer recurrence will be evaluated with 68Ga PSMA 11 PET/CT and conventional imaging. The outcome will be reported as the percentage of participants for whom tumor lesions are identified by 68Ga PSMA 11 PET/CT, and for whom tumor lesions are identified by histopathology/biopsy and/or conventional imaging follow up. The outcome is reported as percentages without dispersion.


Secondary Outcome Measures :
  1. Sensitivity of 68GA-PSMA PET/CT [ Time Frame: 12 months ]
    Point estimates and 95% confidence intervals will be calculated. Sites of suspected metastatic disease will be graded on a three-point scale (0=Negative, 1=Equivocal, 2=Positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively.

  2. Specificity of 68GA-PSMA PET/CT [ Time Frame: 12 months ]
    Point estimates and 95% confidence intervals will be calculated. Sites of suspected metastatic disease will be graded on a three-point scale (0=Negative, 1=Equivocal, 2=Positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively.

  3. 68Ga PSMA 11 PET/CT Predictive Value by Participant [ Time Frame: 12 months ]
    : The predictive value of 68Ga PSMA 11 PET/CT for detection of tumor, as confirmed by conventional imaging follow up and/or histopathology/biopsy, within the following 1 year, is assessed by participant. Positive predictive value (PPV) is the probability that participants identified by 68Ga PSMA 11 PET/CT as having prostate cancer recurrence, do have prostate cancer recurrence. Negative predictive value (NPV) is the probability that participants not identified by 68Ga PSMA 11 PET/CT as having prostate cancer recurrence, do not have prostate cancer recurrence. The outcome is reported as the PPV and the NPV of 68Ga PSMA 11 PET/CT for confirmation of prostate cancer recurrence by participant, with 95% confidence interval.

  4. 68Ga PSMA 11 PET/CT Predictive Value by Region [ Time Frame: 12 months ]
    : The predictive value of 68Ga PSMA 11 PET/CT for detection of tumor location, as confirmed by conventional imaging follow up and/or histopathology/biopsy, within the following 1 year, is assessed by region [prostate bed; pelvis outside of prostate bed including lymph nodes; extrapelvic soft tissue; lymph nodes; and organ metastases (non bone); and bone metastases]. Negative predictive value (NPV) is the probability that participants not identified by 68Ga PSMA 11 PET/CT as having prostate cancer recurrence, do not have prostate cancer recurrence. The outcome is reported as the PPV and the NPV of 68Ga PSMA 11 PET/CT for confirmation of prostate cancer recurrence by region, with 95% confidence interval.

  5. 68Ga PSMA 11 PET/CT Per patient Tumor Detection Rates [ Time Frame: 12 months ]
    68Ga PSMA 11 PET/CT tumor detection rates by patient, stratified by PSA value in ng/mL (0.2 to < 0.5; 0.5 to < 1.0; 1.0 to < 2.0; 2.0 to < 5.0; ≥ 5.0), are reported with mean ± SD and 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
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) - American Urology Association (AUA) recommendation

      • PSA greater than 0.2 ng/mL measured 6-13 weeks after RP
      • Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
    • Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

      • A rise of PSA measurement of 2 or more ng/mL over the nadir
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

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.

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): NCT02673151


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Andrei Iagaru
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrei Iagaru Stanford University
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Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02673151    
Other Study ID Numbers: IRB-35932
NCI-2016-00094 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0076 ( Other Identifier: OnCore )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
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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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents