Trial Outcomes & Findings for Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer (NCT NCT00928252)

Results Overview

Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

21 to 98 days

Results posted on

2017-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Received 18F-fluorocholine PET/CT 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV).
Overall Study STARTED	45
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Received 18F-fluorocholine PET/CT 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV).
Overall Study Physician Decision	3

Baseline Characteristics

Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=42 Participants 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	42 Participants n=39 Participants
Age, Continuous	73 Years n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	42 Participants n=39 Participants
Region of Enrollment United States	42 Participants n=39 Participants

PRIMARY outcome

Timeframe: 21 to 98 days

Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT

Outcome measures

Outcome measures
Measure	Received 18F-fluorocholine PET/CT n=42 Participants IV fluorine-18 labeled methylcholine before PET/CT IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.
Metabolically Active Tumor Volume (MATV) Response	20 Participants

PRIMARY outcome

Timeframe: 2 years

Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.

Outcome measures

Outcome measures
Measure	Received 18F-fluorocholine PET/CT n=42 Participants IV fluorine-18 labeled methylcholine before PET/CT IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.
Time to PSA Progression MATV reduction > or = 30%	194 days Standard Error 13.759
Time to PSA Progression MATV reduction < 30%	116 days Standard Error 26.929

PRIMARY outcome

Timeframe: Up to 15 week post-chemotherapy

Population: Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.

PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.

Outcome measures

Outcome measures
Measure	Received 18F-fluorocholine PET/CT n=42 Participants IV fluorine-18 labeled methylcholine before PET/CT IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.
Proportional Hazards Regression Analysis of Time to PSA Progression	0.246 Hazard Ratio Interval 0.083 to 0.728

Adverse Events

Single Arm

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=45 participants at risk 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.
Musculoskeletal and connective tissue disorders Severe Back Pain	2.2% 1/45 • Number of events 1
Infections and infestations Cellulitis	2.2% 1/45 • Number of events 1
Cardiac disorders Myocardial Ischemia, Diagnosis	2.2% 1/45 • Number of events 1
Infections and infestations Severe Influenza	2.2% 1/45 • Number of events 1
Renal and urinary disorders Obstructive Uropathy	2.2% 1/45 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Sandi Kwee, MD, PhD

The Queen's Medical Center

Phone: 8086915466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place