68Ga-PSMA-11 PET in Patients With Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Computed Tomography
- Conditions
- Not specified
- Sponsor
- University of Washington
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Change in planned management strategy
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.
Detailed Description
OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study. After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically proven prostate adenocarcinoma
- •For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
- •Grade group 4-5 and/or
- •PSA \> 20 ng/mL
- •For patients with biochemical recurrence (biochemical recurrence cohort):
- •Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
- •If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
- •If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
- •For patients undergoing systemic therapy (treatment monitoring cohort):
- •Diagnosis of metastatic castration-resistant prostate cancer
Exclusion Criteria
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Arms & Interventions
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Computed Tomography
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Gallium Ga 68 Gozetotide
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Positron Emission Tomography
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Magnetic Resonance Imaging
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Bone Scan
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
Intervention: Electronic Health Record Review
Outcomes
Primary Outcomes
Change in planned management strategy
Time Frame: Baseline up to 1.5 years after the last scan
Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.
Secondary Outcomes
- Major change in management(Baseline up to 5 years post-scan)
- Minor change in management(Baseline up to 5 years post-scan)
- 68Ga-PSMA-11 standardized uptake value maximum (SUVmax)(Up to 6 weeks after systemic therapy initiation)
- 68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)(Up to 6 weeks after systemic therapy initiation)
- Change in 68Ga-PSMA-11 SUVmax(Baseline up to 6 weeks after systemic therapy initiation)
- Change in 68Ga-PSMA-11 SULpeak(Baseline up to 6 weeks after systemic therapy initiation)
- Change in size of measurable metastatic lesions(Baseline up to 5 years post-scan)
- Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens(Up to 5 years post-scan)
- Change in PSMA total tumor volume(Baseline up to 5 years post-scan)