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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:

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.

Condition or disease Intervention/treatment
Hormone Refractory Prostate Cancer Prostate Cancer Procedure: Phlebotomy

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Study Type : Observational
Actual Enrollment : 276 participants
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
Study Start Date : December 2004
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Metastatic Hormone Refractory Prostate Cancer Patients
Procedure: Phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133900

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United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
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Principal Investigator: Ken Pienta, MD University of Michigan
Principal Investigator: Derek Raghavan, M.D. The Cleveland Clinic
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Senior Director, Clinical Development, Immunicon Identifier: NCT00133900    
Other Study ID Numbers: IMMC-38
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: March 2008
Keywords provided by Immunicon:
hormone refractory prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes