Trials / Withdrawn
WithdrawnNCT05034562
Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.
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.
Conditions
- Metastatic Prostate Carcinoma
- Recurrent Prostate Carcinoma
- Stage IV Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo PET/CT |
| DRUG | Gallium Ga 68-labeled PSMA-11 | Given IV |
| PROCEDURE | Magnetic Resonance Imaging | Undergo PET/MRI |
| PROCEDURE | Positron Emission Tomography | Undergo PET/CT or PET/MRI |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2022-09-26
- Completion
- 2022-09-26
- First posted
- 2021-09-05
- Last updated
- 2024-03-07
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05034562. Inclusion in this directory is not an endorsement.