Expired Study
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San Francisco, California 94158


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02397408


Primary Contact:

Principal Investigator
Albert Chang, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94158
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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