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

• Sponsor: Immunicon (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00133900
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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	Phase
Hormone Refractory Prostate Cancer; Prostate Cancer	Procedure: Phlebotomy

Study Design

• 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: Dec 1, 2004
• Anticipated Primary Completion Date: Feb 1, 2009
• Anticipated Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall Survival [Up to 36 months from time of baseline draw]

Secondary Outcome Measures

1. Progression Free Survival [Up to 36 months after baseline draw]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 510(k) Premarket Notification Summary

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00133900
• Other Study ID Numbers: IMMC-38
• First Posted: Aug 24, 2005
• Last Update Posted: Jul 28, 2009
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: hormone refractory prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Neoplastic Cells, Circulating

Study Results

No Results Posted as of Jul 28, 2009