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

Prostate Cancer Clinical Trial

— IMMC-38  

Official title:

Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00133900
• Other study ID #: IMMC-38
• Status: Active, not recruiting
• Phase: N/A
• First received: August 22, 2005
• Last updated: July 27, 2009
• Start date: December 2004
• Est. completion date: February 2009

Study information

• Verified date: March 2008
• Source: Immunicon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Immunicon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Up to 36 months from time of baseline draw	No
Secondary	Progression Free Survival		Up to 36 months after baseline draw	No

External Links

•   510(k) Premarket Notification Summary