Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Overview
- Phase
- Phase 3
- Intervention
- Ga-68 labeled PSMA-11 PET
- Conditions
- Prostate Cancer
- Sponsor
- Thomas Hope
- Enrollment
- 346
- Locations
- 1
- Primary Endpoint
- True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Investigators
Thomas Hope
Assistant Professor
University of California, San Francisco
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Ga-68 labeled PSMA-11 PET
Outcomes
Primary Outcomes
True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
Time Frame: 1 day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
Time Frame: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
Time Frame: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
Time Frame: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Secondary Outcomes
- Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only(1 Day)
- PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only(1 Day)
- PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT)(1 Day)
- PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only(1 Day)
- PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment(1 Day)
- Percent of Participants With a Change in Clinical Management(Up to 6 months)
- Rate of Inter-reader Reproducibility for Positivity(1 Day)
- Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events(Up to 30 days)