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Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy (IMMC-38)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Immunicon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Immunicon
ClinicalTrials.gov Identifier:
NCT00133900
First received: August 22, 2005
Last updated: July 27, 2009
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention
Hormone Refractory Prostate Cancer
Prostate Cancer
 Procedure: Phlebotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Immunicon:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 36 months from time of baseline draw ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 36 months after baseline draw ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum Samples and RNA samples have been retained.


Enrollment: 276
Study Start Date: December 2004
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Metastatic Hormone Refractory Prostate Cancer Patients
 Procedure: Phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Oncology patients from academic institutions and private practices

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133900

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Immunicon
Investigators
Principal Investigator: Ken Pienta, MD University of Michigan
Principal Investigator: Derek Raghavan, M.D. The Cleveland Clinic
  More Information

Additional Information:
510(k) Premarket Notification Summary  This link exits the ClinicalTrials.gov site

No publications provided by Immunicon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Senior Director, Clinical Development, Immunicon
ClinicalTrials.gov Identifier: NCT00133900     History of Changes
Other Study ID Numbers: IMMC-38
Study First Received: August 22, 2005
Last Updated: July 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Immunicon:
hormone refractory prostate cancer

Additional relevant MeSH terms:
Neoplastic Cells, Circulating
Prostatic Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
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