Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Queen's Medical Centre
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT00928252
First received: June 24, 2009
Last updated: August 1, 2014
Last verified: August 2014

June 24, 2009
August 1, 2014
June 2009
July 2015   (final data collection date for primary outcome measure)
PSA Outcome [ Time Frame: 12 week post-chemotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928252 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hormone Refractory Prostate Cancer
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.
Experimental: Single Arm
18F-fluoromethylcholine IV in conjunction with PET/CT imaging
Intervention: Drug: IV administration of fluorine-18 labeled methylcholine followed by PET/CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provision of written informed consent.
  2. Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
  3. History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
  4. 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.
  5. A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
  6. Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T.

Exclusion Criteria:

  1. 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.
  2. Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
  3. Patient weighs over 350 lbs (due to scanner weight limit).
  4. Clinical life expectancy < 12 weeks.
  5. 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.
  6. 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 approved study protocol.
Male
18 Years and older
No
Contact: Miles Sato, MS 808-691-8584 msato@queens.org
Contact: Sandi Kwee, MD 808-691-5466 skwee@queens.org
United States
 
NCT00928252
RA-2008-069, R21CA139687
No
Sandi Kwee, Queen's Medical Centre
Queen's Medical Centre
National Institutes of Health (NIH)
Principal Investigator: Sandi A Kwee, MD The Queen's Medical Center
Queen's Medical Centre
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP