Trial Outcomes & Findings for 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer (NCT NCT02397408)

NCT ID: NCT02397408

Last Updated: 2020-11-19

Results Overview

The average K1 values of primary tumors will be reported along with the standard deviation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2020-11-19

Participant Flow

Patients were recruited from the Division of Radiation Oncology, Division Urological Medical Oncology, and the Division of Urologic Surgical Oncology at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF) who are planning to undergo radical prostatectomy of definitive radiation therapy.

Participant milestones

Measure	Diagnostic 11C- and 18F-choline PET/MR Imaging Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
Overall Study STARTED	18
Overall Study Completed Surgery Per Protocol	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Diagnostic 11C- and 18F-choline PET/MR Imaging Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
Overall Study Physician Decision	4
Overall Study Surgery not completed within protocol timeframe	2

Baseline Characteristics

Baseline PSA was calculated for patients whom completed and were used in final analysis

Baseline characteristics by cohort

Measure	Diagnostic 11C- and 18F-choline PET/MR Imaging n=18 Participants Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
Age, Customized 50-59 years old	5 Participants n=18 Participants
Age, Customized 60-69 years old	8 Participants n=18 Participants
Age, Customized 70-79 years old	5 Participants n=18 Participants
Sex: Female, Male Female	0 Participants n=18 Participants
Sex: Female, Male Male	18 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	4 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants
Race (NIH/OMB) White	11 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=18 Participants
Region of Enrollment United States	18 participants n=18 Participants
Serum Prostate-Specific Antigen (PSA) Level	21.1 nanograms per millilitre (ng/mL) STANDARD_DEVIATION 18.5 • n=12 Participants • Baseline PSA was calculated for patients whom completed and were used in final analysis

PRIMARY outcome

Timeframe: Day 1

The average K1 values of primary tumors will be reported along with the standard deviation

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1)	0.562 K1 (min-1) Standard Deviation 0.201

PRIMARY outcome

Timeframe: Day 1

The K1max values of primary tumors will be reported along with the standard deviation

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)	0.753 K1 (min-1) Standard Deviation 0.246

PRIMARY outcome

Timeframe: Day 1

The SUVavg values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Average Standardized Uptake Value (SUVavg)	6.10 SUV Standard Deviation 1.60

PRIMARY outcome

Timeframe: Day 1

The SUVmax values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Mean of the Standardized Uptake Value (SUVmax)	8.40 SUV Standard Deviation 2.04

PRIMARY outcome

Timeframe: Day 1

Sensitivity (True Positive Rate, TPR) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher sensitivity to identify the prostate cancer using SUVmax . The sensitivity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging	88 percentage of true positives

PRIMARY outcome

Timeframe: Day 1

Specificity (True Negative Rate) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher specificity to identify the prostate cancer using SUVmax. The specificity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging	100 percentage of true negatives

PRIMARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of K1 with K1max. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of K1 of Primary Tumors With K1max	0.86 Spearman's correlation coefficient (ρ)

PRIMARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of K1 with the SUVavg of primary tumors. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg)	0.76 Spearman's correlation coefficient (ρ)

PRIMARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of K1max with SUVmax. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of K1max of Primary Tumors With SUVmax	0.65 Spearman's correlation coefficient (ρ)

PRIMARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of K1max with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of K1max of Primary Tumors With SUVavg	0.60 Spearman's correlation coefficient (ρ)

PRIMARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of SUVmax with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of SUVmax of Primary Tumors With SUVavg	0.65 Spearman's correlation coefficient (ρ)

SECONDARY outcome

Timeframe: Day 1

A spearman rank correlation test was performed to test the correlation of SUVmax with a patients baseline PSA. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level	0.71 Spearman rank correlation coefficient (p

SECONDARY outcome

Timeframe: Day 1

The system of pathological staging is developed by the American Joint Committee on Cancer (AJCC) and is divided into 5 stages: stage 0 (zero) and stages I through IV (1 through 4). A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's baseline pathological stage. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of SUVmax of Primary Tumors With Pathological Stage	0.59 Spearman rank correlation coefficient (p

SECONDARY outcome

Timeframe: After surgery, Up to 6 months

The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's CAPRA score after surgery. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores	0.72 Spearman rank correlation coefficient (p

SECONDARY outcome

Timeframe: After surgery, Up to 6 months

The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A Mann-Whitney U test was performed to compare the SUVmax with patients classified as intermediate-risk and high risk based on their CAPRA Score. Means and standard deviations will be reported.

Outcome measures

Measure	Choline PET/MR n=12 Participants 11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously Choline PET/MR
Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups Intermediate Risk Group	9.53 SUVmax Standard Deviation 1.48
Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups High Risk Group	6.24 SUVmax Standard Deviation 1.26

Adverse Events

Diagnostic 11C- and 18F-choline PET/MR Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Albert J. Chang, MD, PhD

University of California, Los Angeles

Phone: (310) 82509771

Email: ajchang@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place