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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Queen's Medical Centre
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT00928252
First received: June 24, 2009
Last updated: February 6, 2015
Last verified: February 2015
  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 fluorine-18 labeled methylcholine before 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 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
18F-fluoromethylcholine IV in conjunction with PET/CT imaging
Drug: IV fluorine-18 labeled methylcholine before PET/CT
Intervention at pre-treatment, and at two timepoints post treatment intiation.

Detailed Description:

Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928252

Contacts
Contact: Miles Sato, MS 808-691-8584 msato@queens.org
Contact: Sandi Kwee, MD 808-691-5466 skwee@queens.org

Locations
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Miles Sato, MS    808-691-8584    msato@queens.org   
Contact: Sandi A Kwee, MD    808-691-5466    skwee@queens.org   
Principal Investigator: Sandi A Kwee, MD         
Sponsors and Collaborators
Queen's Medical Centre
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: February 6, 2015
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on July 29, 2015