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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DNA analysis
DNA methylation analysis
RNA analysis
gene expression analysis
polymerase chain reaction
diagnostic laboratory biomarker analysis
therapeutic conventional surgery
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (specimen collection)

Arm Description

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.

Outcomes

Primary Outcome Measures

Performance of these models in predicting the likelihood of BCR
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
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
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
Logistic regression and artificial neural networks will be used.

Full Information

First Posted
September 12, 2009
Last Updated
March 17, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00977457
Brief Title
Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery
Official Title
Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2007 (Actual)
Primary Completion Date
July 13, 2016 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1045 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (specimen collection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Genetic
Intervention Name(s)
DNA methylation analysis
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Description
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Other Intervention Name(s)
Undergo robotic prostatectomy or cystoprostatectomy
Primary Outcome Measure Information:
Title
Performance of these models in predicting the likelihood of BCR
Description
Logistic regression and artificial neural networks will be used.
Time Frame
Visit 2 (intraoperative setting)
Secondary Outcome Measure Information:
Title
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
Description
Logistic regression and artificial neural networks will be used.
Time Frame
Visit 2 (intraoperative setting)
Title
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
Description
Logistic regression and artificial neural networks will be used.
Time Frame
Visit 2 (intraoperative setting)
Title
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens
Description
Logistic regression and artificial neural networks will be used.
Time Frame
Visit 2 (intraoperative setting)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven S. Smith, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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