Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
IMMC-38
Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
1 other identifier
observational
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 28, 2009
March 1, 2008
4.2 years
August 22, 2005
July 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Up to 36 months from time of baseline draw
Secondary Outcomes (1)
Progression Free Survival
Up to 36 months after baseline draw
Study Arms (1)
Cohort
Metastatic Hormone Refractory Prostate Cancer Patients
Interventions
Eligibility Criteria
Oncology patients from academic institutions and private practices
You may qualify if:
- 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
You may not qualify if:
- Systemic radiation
- Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
- Brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immuniconlead
Study Sites (1)
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Related Publications (1)
Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
PMID: 23014524DERIVED
Related Links
Biospecimen
Serum Samples and RNA samples have been retained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Pienta, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Derek Raghavan, M.D.
The Cleveland Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
December 1, 2004
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 28, 2009
Record last verified: 2008-03