68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 1138
- Locations
- 1
- Primary Endpoint
- Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location
Time Frame: 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 Outcomes
- 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)
- 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)
- Clinical management in biochemical recurrence patients(Up to 12 months)
- Inter-reader reproducibility(Up to 12 months)
- 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)
- 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)
- Incidence of adverse events(Up to 12 months)