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

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ClinicalTrials.gov Identifier: NCT00928252
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre

Tracking Information
First Submitted Date  ICMJE June 24, 2009
First Posted Date  ICMJE June 25, 2009
Results First Submitted Date  ICMJE June 19, 2017
Results First Posted Date  ICMJE August 14, 2017
Last Update Posted Date August 14, 2017
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • Metabolically Active Tumor Volume (MATV) Response [ Time Frame: 21 to 98 days ]
    Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
  • Time to PSA Progression [ Time Frame: 2 years ]
    Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
  • Proportional Hazards Regression Analysis of Time to PSA Progression [ Time Frame: Up to 15 week post-chemotherapy ]
    PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
PSA Outcome [ Time Frame: 12 week post-chemotherapy ]
Change History Complete list of historical versions of study NCT00928252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • Brief Pain Inventory [ Time Frame: post-chemotherapy ]
  • Quality of Life (QLQ-30) [ Time Frame: post-chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Official Title  ICMJE Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hormone Refractory Prostate Cancer
Intervention  ICMJE Drug: IV fluorine-18 labeled methylcholine before PET/CT
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Other Name: 18F-fluorocholine PET/CT
Study Arms  ICMJE Experimental: Received 18F-fluorocholine PET/CT
IV fluorine-18 labeled methylcholine before PET/CT
Intervention: Drug: IV fluorine-18 labeled methylcholine before PET/CT
Publications * Lee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2009)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928252
Other Study ID Numbers  ICMJE RA-2008-069
R21CA139687 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandi Kwee, Queen's Medical Centre
Study Sponsor  ICMJE Queen's Medical Centre
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sandi A Kwee, MD The Queen's Medical Center
PRS Account Queen's Medical Centre
Verification Date July 2017

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