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Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00977457
First received: September 12, 2009
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer


Condition Intervention
Prostate Cancer
Genetic: DNA analysis
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Performance of these models in predicting the likelihood of BCR [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
    Logistic regression and artificial neural networks will be used.


Secondary Outcome Measures:
  • Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
    Logistic regression and artificial neural networks will be used.

  • Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
    Logistic regression and artificial neural networks will be used.

  • Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
    Logistic regression and artificial neural networks will be used.


Estimated Enrollment: 1200
Study Start Date: July 2007
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. 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.
Genetic: DNA analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Genetic: DNA methylation analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Genetic: RNA analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Genetic: gene expression analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Genetic: polymerase chain reaction
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Other: diagnostic laboratory biomarker analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Procedure: therapeutic conventional surgery
Other Name: Undergo robotic prostatectomy or cystoprostatectomy

Detailed Description:

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. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977457

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Medical Center    800-826-4673      
Principal Investigator: Steven Smith, PhD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Steven S. Smith, PhD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00977457     History of Changes
Other Study ID Numbers: 06072, P30CA033572, CHNMC-06072, CDR0000644208, 5R01CA102521, NCI-2011-00980
Study First Received: September 12, 2009
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014