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Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence


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

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Trial Information

Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence


PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the
likelihood of biochemical recurrence (BCR).

SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading
and upstaging prior to surgery. II. To explore the performance of these models in improving
risk stratification among patients eligible for active surveillance.

OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE).
Laboratory assessments are performed and blood samples are collected for molecular biology
testing. On the day of the scheduled prostatectomy, a second blood collection is performed
prior to surgery.


Inclusion Criteria:



- All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be
eligible for the study

Exclusion Criteria:

- Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage
prostatectomy including those who have had brachytherapy will be excluded

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Performance of this model in predicting the likelihood of BCR

Outcome Description:

Logistic regression and artificial neural networks will be used.

Outcome Time Frame:

Visit 2 (intraoperative setting)

Safety Issue:

No

Principal Investigator

Steven S. Smith, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

06072

NCT ID:

NCT00977457

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms
  • Recurrence

Name

Location
City of Hope Medical Center Duarte, California  91010