Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: No
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• 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).

Locations
United States
Hawaii
The Queen's Medical Center
Honolulu
Time Frame
Start Date: June 2009
Completion Date: July 2013
Participants
Target number of participants: 27
Treatments
Experimental: Single Arm
Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Queen's Medical Center

This content was sourced from clinicaltrials.gov

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