11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/24/2018 |
| Start Date: | April 2, 2015 |
| End Date: | November 22, 2016 |
Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer
This is a phase 2 study to assess the ability of 11C- and 18F-choline to detect and localize
prostate cancer within the prostate gland in patients with unfavorable intermediate to
high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C-
and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in
patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to
assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of
metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical
prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C-
and 18F-choline PET imaging in the detection and localization of local and metastatic disease
with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI, advanced body
NaF PET/CT), and to determine the temporal distribution of 11C- and 18F-choline radiotracer
in patients. The tissue uptake, retention, and clearance will be determined. An exploratory
objective comparing regions of uptake from the 11C- and 18F-choline PET/MR and sentinel lymph
node imaging will be performed.
prostate cancer within the prostate gland in patients with unfavorable intermediate to
high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C-
and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in
patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to
assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of
metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical
prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C-
and 18F-choline PET imaging in the detection and localization of local and metastatic disease
with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI, advanced body
NaF PET/CT), and to determine the temporal distribution of 11C- and 18F-choline radiotracer
in patients. The tissue uptake, retention, and clearance will be determined. An exploratory
objective comparing regions of uptake from the 11C- and 18F-choline PET/MR and sentinel lymph
node imaging will be performed.
Inclusion Criteria:
- Age: Patients must be ≥18 years of age
- Diagnosis: Patients must have a diagnosis of prostate cancer by histologic
verification and a hypoechoic lesion seen on ultrasound.
- Disease Status: Unfavorable intermediate to high-risk prostate Cancer (CAPRA 5-10)
- Karnofsky Performance Status ≥70
- Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
- Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
- Adequate bone marrow and organ function defined as follows:
- Adequate bone marrow function:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Adequate hepatic function:
- Total bilirubin - within normal institutional limits
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Adequate renal function:
- Creatinine - within normal institutional limits OR
- Creatinine clearance ≥ 60 mL/min/1.73m2 for patients with creatinine levels above
institutional normal
- Ability to understand a written informed consent document, and the willingness to sign
it
Exclusion Criteria:
- Participation would significantly delay the scheduled standard of care therapy
- Karnofsky performance status of < 60
- Inadequate venous access
- Administered a radioisotope within 5 physical half lives prior to study enrollment
- Have a medical condition or other circumstances which, in the opinion of the
investigator would significantly decrease the chances of obtaining reliable data,
achieving the study objectives, or completing the study.
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