Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
- Conditions
- Prostate Cancer
- Interventions
- Drug: Ga-68 labeled PSMA-11 PET
- Registration Number
- NCT03353740
- Lead Sponsor
- Thomas Hope
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 346
Not provided
Not provided
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 True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up 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 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 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 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 Outcome Measures
Name Time Method Rate of Inter-reader Reproducibility for Positivity 1 Day Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers
Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events Up to 30 days All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug.
Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only 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 only.
True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only 1 Day The true positive rate or detection rate 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 only.
PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy
PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value 1 Day Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- \<0.5, 0.5 - \<1.0, 1.0 - \<2.0, 2.0 - \<5.0, \>=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up.
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) 1 Day Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format.
PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy
PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment 1 Day Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format.
Percent of Participants With a Change in Clinical Management Up to 6 months Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys.
PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. 1 Day Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only 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 only.
True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only 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 only.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States