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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00977457

Collaborator

National Cancer Institute (NCI) (NIH)

1,200

Enrollment

Location

Arm

181.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence

Actual Study Start Date :

Nov 26, 2007

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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 Names: Undergo robotic prostatectomy or cystoprostatectomy

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