11C- and 18F-Choline PET/MR Imaging for Prostate Cancer

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Mar 18, 2015

Keywords

ClinConnect Summary

PRIMARY OBJECTIVES:

I. To assess the ability of 11C- and 18F-choline PET/MR to detect and localize prostate cancer within the prostate gland.

SECONDARY OBJECTIVES:

I. 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.

II. To assess the comparative performance of 11C- and 18F-choline PET/MR to already available imaging scans (bone scan, sodium fluoride positron emission tomography/computed tomography \[NaF...

Gender

ALL

Eligibility 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, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (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/microliter (mcL)
• • Absolute Neutrophil Count \>= 1,500/mcL
• • Platelets \>= 100,000/mcL
• * Adequate hepatic function:
• • Total bilirubin - within normal institutional limits
• • Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 X institutional upper limit of normal
• • Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (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.