- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928174
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer
October 13, 2015 updated by: Sandi Kwee, Queen's Medical Center
The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
-
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Hawaii
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Honolulu, Hawaii, United States, 96813
- The Queen's Medical Center
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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 to 120 years (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
- Serum testosterone level < 50 ng/ml. Castrate testosterone levels must be from orchiectomy or current therapy with leutinizing hormone-releasing hormone agonist.
- Progressive disease evidenced by two consecutive rises in prostate specific antigen (PSA) above a nadir value, with the absolute value of the latest PSA > 2. 0 ng/ml.
- Patient will be undergoing a therapeutic intervention under the supervision of his treating physician (urologist, oncologist).
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 hormonal therapy; concurrent leuteinizing hormone releasing hormone (LHRH) agonist; prior surgery; prior or concurrent bisphosphonate. Not allowed: concurrent anti-androgen or secondary hormonal therapy, prior or concurrent chemotherapy, concurrent radiotherapy or radioisotope therapy (e.g., strontium). Other: Prior radiotherapy or radioisotope therapy must be > 12 weeks since last treatment.
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: Single Arm
Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
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Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
Time Frame: Concurrent with PET Procedure
|
The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.
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Concurrent with PET Procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
July 1, 2013
Study Completion (Actual)
July 1, 2013
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 (Estimate)
November 11, 2015
Last Update Submitted That Met QC Criteria
October 13, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA-2009-009
- 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.
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