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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Immunicon.
Recruitment status was:  Active, not recruiting
Information provided by:
Immunicon Identifier:
First received: August 22, 2005
Last updated: July 27, 2009
Last verified: March 2008
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:

Further study details as provided by Immunicon:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 36 months from time of baseline draw ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 36 months after baseline draw ]

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
Metastatic Hormone Refractory Prostate Cancer Patients
Procedure: Phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Oncology patients from academic institutions and private practices

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
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Please refer to this study by its identifier: NCT00133900

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Senior Director, Clinical Development, Immunicon Identifier: NCT00133900     History of Changes
Other Study ID Numbers: IMMC-38
Study First Received: August 22, 2005
Last Updated: July 27, 2009

Keywords provided by Immunicon:
hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 27, 2017