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

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ClinicalTrials.gov Identifier: NCT00977457
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
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 or disease Intervention/treatment
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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
Study Start Date : November 26, 2007
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Performance of these models in predicting the likelihood of BCR [ Time Frame: Visit 2 (intraoperative setting) ]
    Logistic regression and artificial neural networks will be used.


Secondary Outcome Measures :
  1. Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery [ Time Frame: Visit 2 (intraoperative setting) ]
    Logistic regression and artificial neural networks will be used.

  2. Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance [ Time Frame: Visit 2 (intraoperative setting) ]
    Logistic regression and artificial neural networks will be used.

  3. 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) ]
    Logistic regression and artificial neural networks will be used.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977457


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven S. Smith, PhD City of Hope Medical Center

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00977457     History of Changes
Other Study ID Numbers: 06072
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-06072
CDR0000644208 ( Registry Identifier: NCI PDQ )
5R01CA102521 ( U.S. NIH Grant/Contract )
NCI-2011-00980 ( Registry Identifier: NCI CTRP )
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes