- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928252
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
July 13, 2017 updated by: Sandi Kwee, Queen's Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- The Queen's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Received 18F-fluorocholine PET/CT
IV fluorine-18 labeled methylcholine before PET/CT
|
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolically Active Tumor Volume (MATV) Response
Time Frame: 21 to 98 days
|
Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
|
21 to 98 days
|
Time to PSA Progression
Time Frame: 2 years
|
Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
|
2 years
|
Proportional Hazards Regression Analysis of Time to PSA Progression
Time Frame: Up to 15 week post-chemotherapy
|
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.
|
Up to 15 week post-chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandi A Kwee, MD, The Queen's Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 24, 2009
First Submitted That Met QC Criteria
June 24, 2009
First Posted (Estimate)
June 25, 2009
Study Record Updates
Last Update Posted (Actual)
August 14, 2017
Last Update Submitted That Met QC Criteria
July 13, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA-2008-069
- R21CA139687 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hormone Refractory Prostate Cancer
-
University of California, IrvineBristol-Myers SquibbCompletedRecurrent Prostate Cancer | Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Hormone-refractory Prostate CancerUnited States
-
DendreonCompletedHormone Refractory Prostate Cancer | Castration-resistant Prostate Cancer | Prostate Cancer MetastaticUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownHormone Refractory Prostate Cancer | Metastatic Prostate CarcinomaChina
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Hormone-refractory Prostate CancerUnited States
-
PfizerAstellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.CompletedProstate Cancer | Hormone Refractory Prostate CancerUnited States
-
Spanish Oncology Genito-Urinary GroupAstellas Pharma Inc; Apices Soluciones S.L.CompletedHormone-refractory Prostate CancerSpain
-
Peking UniversityWithdrawnHormone Refractory Prostate CancerChina
-
Tianjin Medical University Cancer Institute and...UnknownHormone Refractory Prostate CancerChina
-
CytoVac A/SCompletedHormone-refractory Prostate CancerDenmark
-
British Columbia Cancer AgencyCompletedHormone Refractory Prostate CancerCanada
Clinical Trials on IV fluorine-18 labeled methylcholine before PET/CT
-
Xuzhou Medical UniversityUniversity of North Carolina, Chapel HillUnknownNasopharyngeal Carcinoma
-
The Methodist Hospital Research InstituteUniversity of California, Los AngelesTerminatedGlioma | Glioblastoma | Glioblastoma MultiformeUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedHead and Neck CancerUnited States
-
Queen's Medical CenterNational Institutes of Health (NIH)CompletedProstate CancerUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Progenics Pharmaceuticals, Inc.Not yet recruitingProstate Adenocarcinoma | Castration Resistant Prostate Cancer | Castration Sensitive Prostate CancerUnited States
-
Bangalore Institute of OncologyUnknown
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingProstate CarcinomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)WithdrawnRecurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage IV Prostate CancerUnited States
-
University of WashingtonActive, not recruitingEstrogen Receptor Positive | Stage IV Breast Cancer AJCC v6 and v7 | Primary or Recurrent Breast CarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterGE HealthcareCompletedBreast CancerUnited States