Measurement of Anti-Androgen Response Using 18F-choline PET/CT in Androgen-Insensitive Prostate Cancer
This study is currently recruiting participants.
Verified August 2012 by Queen's Medical Centre
Sponsor:
Queen's Medical Centre
Collaborator:
National Cancer Institute (funding source)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT00928174
First received: June 24, 2009
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: IV administration of fluorine-18 methylcholine followed by PET/CT imaging |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Measurement of Anti-Androgen Response Using 18F-choline PET/CT in Androgen-Insensitive Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Queen's Medical Centre:
Primary Outcome Measures:
- PSA Outcome [ Time Frame: 30-75 day follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 21 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: IV administration of fluorine-18 methylcholine followed by PET/CT imaging
Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928174
Contacts
| Contact: Karen Ng, RN | 808-537-7614 | kng@queens.org |
| Contact: Sandi A Kwee, MD | 808-585-5466 | skwee@queens.org |
Locations
| United States, Hawaii | |
| The Queen's Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Karen Ng, RN 808-537-7614 kng@queens.org | |
| Contact: Sandi A Kwee, MD 808-585-5466 skwee@queens.org | |
| Principal Investigator: Sandi A Kwee, MD | |
Sponsors and Collaborators
Queen's Medical Centre
National Cancer Institute (funding source)
Investigators
| Principal Investigator: | Sandi A Kwee, MD | The Queen's Medical Center |
More Information
No publications provided
| Responsible Party: | Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00928174 History of Changes |
| Other Study ID Numbers: | RA-2009-009, R21CA139687 |
| Study First Received: | June 24, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Queen's Medical Centre:
|
Androgen insensitive prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Androgen Antagonists Androgens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hormones |
ClinicalTrials.gov processed this record on May 16, 2013