68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
Overview
- Phase
- Phase 2
- Intervention
- Computed Tomography (CT) scan
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Andrei Iagaru
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.
Investigators
Andrei Iagaru
Professor of Radiology
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Histopathological proven prostate adenocarcinoma
- •Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- •Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation
- •PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
- •Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
- •Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
- •A rise of PSA measurement of 2 or more ng/mL over the nadir
- •Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
- •Able to provide written consent
Exclusion Criteria
- •Investigational therapy for prostate cancer.
- •Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
- •Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Arms & Interventions
68Ga-PSMA-11 PET/CT
Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .
Intervention: Computed Tomography (CT) scan
68Ga-PSMA-11 PET/CT
Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .
Intervention: 68Ga-PSMA-11
68Ga-PSMA-11 PET/CT
Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .
Intervention: Positron Emission Tomography (PET)
Outcomes
Primary Outcomes
Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
Time Frame: up to 12 months
Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
Secondary Outcomes
- 68Ga-PSMA-11 PET/CT Sensitivity and Specificity(up to 12 months)
- 68Ga-PSMA-11 PET/CT Predictive Value by Region(up to 12 months)
- Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level(up to 12 months)