Clinical trial NCT02397408: 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
Official title: Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed description: 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 \[NaF PET/CT\], multiparametric1H magnetic resonance imaging \[MRI\], and/or pelvic CT scans) for detecting and localization of disease within the prostate, lymph nodes, and distant metastatic sites.

III. To determine the temporal distribution of 11C- and 18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be determined.

EXPLORATORY OBJECTIVES:

I. To compare regions of uptake on the 11C- and 18F-choline PET/MR to that on the sentinel lymph node imaging scans in patients undergoing sentinel lymph node-guided extended pelvic lymph node dissection.

OUTLINE:

Patients undergo 11C- and 18F-choline whole-body PET/MR imaging. After completion of study treatment, patients are followed up for 3 hours

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.

Primary outcomes:
measure: Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1)
timeFrame: Day 1
measure: Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)
timeFrame: Day 1
measure: Average Standardized Uptake Value (SUVavg)
timeFrame: Day 1
measure: Mean of the Standardized Uptake Value (SUVmax)
timeFrame: Day 1
measure: Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging
timeFrame: Day 1
measure: Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging
timeFrame: Day 1
measure: Correlation of K1 of Primary Tumors With K1max
timeFrame: Day 1
measure: Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg)
timeFrame: Day 1
measure: Correlation of K1max of Primary Tumors With SUVmax
timeFrame: Day 1
measure: Correlation of K1max of Primary Tumors With SUVavg
timeFrame: Day 1
measure: Correlation of SUVmax of Primary Tumors With SUVavg
timeFrame: Day 1
Secondary outcomes:
measure: Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level
timeFrame: Day 1
measure: Correlation of SUVmax of Primary Tumors With Pathological Stage
timeFrame: Day 1
measure: Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores
timeFrame: After surgery, Up to 6 months
measure: Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups
timeFrame: After surgery, Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Albert J Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi JY, Yang J, Noworolski SM, Behr S, Chang AJ, Simko JP, Nguyen HG, Carroll PR, Kurhanewicz J, Seo Y. 18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons. Radiology. 2017 Feb;282(2):429-436. doi: 10.1148/radiol.2016160220. Epub 2016 Aug 11.