Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
Study Details
Study Description
Brief Summary
This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVE:
- To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
SECONDARY OBJECTIVES:
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To assess the 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, clinical and conventional imaging follow-up (composite reference standard).
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To assess 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 only.
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To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).
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To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.
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To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET.
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To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
After completion of study, patients are followed up for 3-12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (68Ga-PSMA-11) Patients receive gallium Ga 68-labeled PSMA-11 IV. Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging. |
Radiation: Gallium Ga 68 Gozetotide
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Positron Emission Tomography
Undergo PET imaging
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [Up to 12 months]
Confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method.
Secondary Outcome Measures
- Positive predictive value (PPV) on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [Up to 12 months]
Confirmed by histopathology/biopsy and, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The paired McNemar's test will be used to compare the positive predictive values of gallium Ga 68-labeled PSMA-11 positron emission tomography imaging to the positive predictive values of conventional imaging.
- Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 positron emission tomography (PET) for detection of tumor location confirmed by histopathology/biopsy [Up to 12 months]
Will be summarized in tabular format. Ninety-five confidence intervals of sensitivity, specificity, and net present value (NPV) will be calculated using the Wilson score method.
- Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value [Up to 12 months]
Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
- Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA velocity and PSA doubling-time [Up to 12 months]
Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
- Clinical management in biochemical recurrence patients [Up to 12 months]
The impact of gallium Ga 68-labeled PSMA-11 positron emission tomography on clinical management in biochemical recurrence patients will be evaluated using descriptive statistics.
- Inter-reader reproducibility [Up to 12 months]
Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss' Kappa test for multiple readers.
- Incidence of adverse events [Up to 12 months]
Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events 4.03.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathological proven prostate adenocarcinoma
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Rising PSA after definitive therapy with prostatectomy or radiation therapy.
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Post radical prostatectomy (RP)
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PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
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Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition
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Nadir + greater than or equal to 2 ng/mL rise in PSA
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Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/ World Health Organization [WHO] equivalent)
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Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
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Concomitant investigational therapy
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Known inability to lie flat, remain still or tolerate a PET scan
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
Investigators
- Principal Investigator: Johannes Czernin, MD, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-001095
- NCI-2016-01212