Trials / Completed
CompletedNCT03368547
68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
68Ga-PSMA-11 PET/CT for Staging of Intermediate and High Risk Prostate Cancer Prior to Radical Prostatectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.
Detailed description
PRIMARY OBJECTIVE: I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation. SECONDARY OBJECTIVES: I. To assess the positive and negative predictive value of 68Ga-PSMA-11 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation. II. To assess sensitivity, specificity, positive and negative predictive value of 68Ga- PSMA-11 PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up. OUTLINE: Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 20-50 minutes on day 1. After completion of study, patients are followed up at 2-4 days, then at 12 months.
Conditions
- Prostate Adenocarcinoma
- Stage IIB Prostate Cancer AJCC v7
- Stage III Prostate Cancer AJCC v7
- Stage IV Prostate Cancer AJCC v7
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo PET/CT scan |
| RADIATION | Gallium Ga 68 Gozetotide | Given IV |
| PROCEDURE | Positron Emission Tomography | Undergo PET/CT scan |
Timeline
- Start date
- 2016-12-12
- Primary completion
- 2021-06-18
- Completion
- 2021-06-18
- First posted
- 2017-12-11
- Last updated
- 2023-04-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03368547. Inclusion in this directory is not an endorsement.