Back to resultsChemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Primary Purpose
Hormone Refractory Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IV fluorine-18 labeled methylcholine before PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Hormone Refractory Prostate Cancer focused on measuring Hormone Refractory Prostate Cancer, Castrate Resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent.
- Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
- History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
- Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA > 5.0 ng/ml.
- A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
- Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T.
Exclusion Criteria:
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
- Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
- Patient weighs over 350 lbs (due to scanner weight limit).
- Clinical life expectancy < 12 weeks.
- Participated in other radioactive drug studies where estimated total cumulative dose within 1 year is > 0.05 Sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 Sievert for other organs.
- Concurrent Therapy. Allowed: Prior or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.
Sites / Locations
- The Queen's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Received 18F-fluorocholine PET/CT
Arm Description
IV fluorine-18 labeled methylcholine before PET/CT
Outcomes
Primary Outcome Measures
Metabolically Active Tumor Volume (MATV) Response
Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
Time to PSA Progression
Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
Proportional Hazards Regression Analysis of Time to PSA Progression
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00928252
First Posted
June 24, 2009
Last Updated
July 13, 2017
Sponsor
Queen's Medical Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00928252
Brief Title
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Official Title
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's Medical Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.
Detailed Description
Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer
Keywords
Hormone Refractory Prostate Cancer, Castrate Resistant Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Received 18F-fluorocholine PET/CT
Arm Type
Experimental
Arm Description
IV fluorine-18 labeled methylcholine before PET/CT
Intervention Type
Drug
Intervention Name(s)
IV fluorine-18 labeled methylcholine before PET/CT
Other Intervention Name(s)
18F-fluorocholine PET/CT
Intervention Description
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Primary Outcome Measure Information:
Title
Metabolically Active Tumor Volume (MATV) Response
Description
Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
Time Frame
21 to 98 days
Title
Time to PSA Progression
Description
Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
Time Frame
2 years
Title
Proportional Hazards Regression Analysis of Time to PSA Progression
Description
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.
Time Frame
Up to 15 week post-chemotherapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent.
Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA > 5.0 ng/ml.
A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T.
Exclusion Criteria:
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
Patient weighs over 350 lbs (due to scanner weight limit).
Clinical life expectancy < 12 weeks.
Participated in other radioactive drug studies where estimated total cumulative dose within 1 year is > 0.05 Sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 Sievert for other organs.
Concurrent Therapy. Allowed: Prior or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandi A Kwee, MD
Organizational Affiliation
The Queen's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26912444
Citation
Lee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16.
Results Reference
derived
Learn more about this trial
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
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