Measurement of Anti-Androgen Response Using 18F-choline PET/CT in Androgen-Insensitive Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
First received: June 24, 2009
Last updated: July 31, 2013
Last verified: July 2013
The purpose of this study is to determine whether PET/CT using 18F-choline 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.
Drug: IV administration of fluorine-18 methylcholine followed by PET/CT imaging
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Measurement of Anti-Androgen Response Using 18F-choline PET/CT in Androgen-Insensitive Prostate Cancer
Primary Outcome Measures:
- PSA Outcome [ Time Frame: 30-75 day follow-up ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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).
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928174
|The Queen's Medical Center
|Honolulu, Hawaii, United States, 96813 |
Queen's Medical Centre
||Sandi A Kwee, MD
||The Queen's Medical Center
No publications provided
||Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 24, 2009
||July 31, 2013
||United States: Food and Drug Administration
Keywords provided by Queen's Medical Centre:
Androgen insensitive prostate cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs