Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. 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: I. 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). II. 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. III. 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). IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients. V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. 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.

Official Title
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68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy

Conditions
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Prostate Adenocarcinoma, Recurrent Prostate Carcinoma

Intervention / Treatment
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* Radiation: Gallium Ga 68 Gozetotide
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathological proven prostate adenocarcinoma Rising PSA after definitive therapy with prostatectomy or radiation therapy. Post radical prostatectomy (RP) PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition 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) Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: Concomitant investigational therapy Known inability to lie flat, remain still or tolerate a PET scan 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (68Ga-PSMA-11)<br>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<br>* Given IV<br>* Other names: PSMA-HBED-CC GA-68;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Positron Emission Tomography<br>* Undergo PET imaging<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location | 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to 12 months | 
| 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 | 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. | 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 | 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. | Up to 12 months | 
| 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 | 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. | Up to 12 months | 
| Clinical management in biochemical recurrence patients | 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. | Up to 12 months | 
| Inter-reader reproducibility | Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss' Kappa test for multiple readers. | Up to 12 months | 
| Incidence of adverse events | 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. | Up to 12 months |