Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory 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:
NCT00928252
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 imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Hormone Refractory Prostate Cancer |
Drug: IV administration of fluorine-18 labeled methylcholine followed by PET/CT |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Queen's Medical Centre:
Primary Outcome Measures:
- PSA Outcome [ Time Frame: 12 week post-chemotherapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Brief Pain Inventory [ Time Frame: post-chemotherapy ] [ Designated as safety issue: No ]
- Quality of Life (QLQ-30) [ Time Frame: post-chemotherapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: IV administration of fluorine-18 labeled methylcholine followed by PET/CT
Intervention applied at pre-treatment, after 1 cycle, and after 3 cycles of a docetaxel-based chemotherapy regimen.
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 luteinizing hormone-releasing hormone agonist.
- Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA > 5.0 ng/ml.
- A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
- Patient is under the care of a medical oncologist and has agreed to treatment with a docetaxel-based chemotherapy regimen that is consistent with current standards of care.
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 or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on study protocol (e.g., SWOG S0421: Addition of atrasentan to docetaxel/prednisone). Not allowed: 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: NCT00928252
Contacts
| Contact: Karen Ng, RN | 808-537-7614 | kng@queens.org |
| Contact: Sandi 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: | NCT00928252 History of Changes |
| Other Study ID Numbers: | RA-2008-069, 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:
|
Hormone Refractory Prostate Cancer Castrate Resistant Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013