Status:
COMPLETED
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer
Lead Sponsor:
Queen's Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00928174
Start Date
June 1 2009
End Date
July 1 2013
Last Update
November 11 2015
Active Locations (1)
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1
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813