- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034562
Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To assess the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA11) positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) on a patient level using histopathology or confirmatory imaging as a standard of truth (SoT).
SECONDARY OBJECTIVES:
I. To assess the PPV per-patient for 68Ga-PSMA-11 PET/CT and PET/MRI detection of tumor location confirmed by histopathology/biopsy alone.
II. Demonstrate the safety of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in participants with prostate cancer.
III. Demonstrate the efficacy of 68Ga-PSMA-11 PET/CT or PET/MRI imaging to monitor response to treatment in participants with prostate cancer.
OUTLINE:
Patients receive gallium 68Ga-PSMA-11 intravenously (IV). 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
After completion of study, patients are followed up at 30 and 90 days, then between 3-36 months.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologically proven prostate cancer
- Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- Karnofsky performance status (KPS) >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2)
- Ability to understand and willingness to provide informed consent
- Participants with known metastatic prostate cancer planned to undergo active systemic treatment
Exclusion Criteria:
- Unable to lie flat, still, or tolerate a PET or MRI scan
- Contraindication to optional furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction - (defined as either Ga-68 specific prompt gamma correction or multiple scatter model) is available for the used PET device
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
|
Undergo PET/CT
Other Names:
Undergo PET/MRI
Other Names:
Given IV
Other Names:
Undergo PET/CT or PET/MRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET)
Time Frame: Up to 36 months
|
Positive predictive value will be defined as true positive/(true positive + false positive).
Positive predictive value on a per-participant and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up will be calculated and reported along with the corresponding two-sided 95% confidence intervals.
|
Up to 36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory C Ravizzini, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Edetic Acid
- Gallium 68 PSMA-11
Other Study ID Numbers
- 2019-1203 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-03699 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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