Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Ga-68 labeled PSMA-11 PET

• Registration Number: NCT02918357
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2016-09-15
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Results First Submitted: 2019-09-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-27
• Last Update Submitted: 2019-11-27
• Results First Posted: 2019-12-02
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 385

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ga-68 labeled PSMA-11 PET	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.

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation	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.
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation	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

Name	Time	Method
Sensitivity on a Per-patient Basis	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.
Sensitivity on a Per-region Basis	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.
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value	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).
Inter-reader Agreement Per-region	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).
Percentage of Participants With Change in Clinical Management	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.
Safety Assessment - Heart Rate	1 day	Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up	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.
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up	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.
Safety Assessment - Blood Pressure	1 day	Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States