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


N/A
18 Years
N/A
Open (Enrolling)
Male
Hormone Refractory Prostate Cancer, Prostate Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall Survival

Outcome Time Frame:

Up to 36 months from time of baseline draw

Safety Issue:

No

Principal Investigator

Ken Pienta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

IMMC-38

NCT ID:

NCT00133900

Start Date:

December 2004

Completion Date:

February 2009

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Prostate Cancer
  • hormone refractory prostate cancer
  • Neoplastic Cells, Circulating
  • Prostatic Neoplasms

Name

Location
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195