Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy - Full Text View

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

First Received on August 22, 2005. Last Updated on July 27, 2009 History of Changes

Sponsor:	Immunicon
Information provided by:	Immunicon
ClinicalTrials.gov Identifier:	NCT00133900

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:

MedlinePlus related topics: Cancer Prostate Cancer

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

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 February 09, 2012