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Trial record 1 of 1 for:    IMMC-38
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Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy (IMMC-38)

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ClinicalTrials.gov Identifier: NCT00133900
Recruitment Status : Unknown
Verified March 2008 by Immunicon.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2005
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Immunicon

Tracking Information
First Submitted Date August 22, 2005
First Posted Date August 24, 2005
Last Update Posted Date July 28, 2009
Study Start Date December 2004
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2008)
Overall Survival [ Time Frame: Up to 36 months from time of baseline draw ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: March 17, 2008)
Progression Free Survival [ Time Frame: Up to 36 months after baseline draw ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
Official Title Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
Brief Summary This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum Samples and RNA samples have been retained.
Sampling Method Probability Sample
Study Population Oncology patients from academic institutions and private practices
Condition
  • Hormone Refractory Prostate Cancer
  • Prostate Cancer
Intervention Procedure: Phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells
Study Groups/Cohorts Cohort
Metastatic Hormone Refractory Prostate Cancer Patients
Intervention: Procedure: Phlebotomy
Publications * Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: July 19, 2007)
276
Original Enrollment
 (submitted: August 23, 2005)
200
Estimated Study Completion Date February 2009
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > or = 18 years
  • Pathological diagnosis of adenocarcinoma of the prostate
  • First or later line of chemotherapy
  • Serum testosterone < 50ng/mL
  • ECOG 0-2
  • Serum PSA > or = 5ng/mL
  • PSA progression (2 rises above a reference value)
  • Bone scan within 60 days of enrollment
  • Computed tomography (CT) scan
  • If measurable disease, bone scans every 6-8 months

Exclusion Criteria:

  • Systemic radiation
  • Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
  • Brain metastases
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00133900
Other Study ID Numbers IMMC-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Senior Director, Clinical Development, Immunicon
Study Sponsor Immunicon
Collaborators Not Provided
Investigators
Principal Investigator: Ken Pienta, MD University of Michigan
Principal Investigator: Derek Raghavan, M.D. The Cleveland Clinic
PRS Account Immunicon
Verification Date March 2008