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

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: 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

• Registration Number: NCT00977457
• Lead Sponsor: 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

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 Timeline

• Study Start: 2007-11-26
• Study First Submitted: 2009-09-12
• Study First Submitted QC: 2009-09-12
• Study First Posted: 2009-09-15
• Primary Completion: 2016-07-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Study Completion: 2025-07-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 1045

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (specimen collection)	DNA analysis	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.
Diagnostic (specimen collection)	DNA methylation analysis	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.
Diagnostic (specimen collection)	therapeutic conventional surgery	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.
Diagnostic (specimen collection)	diagnostic laboratory biomarker analysis	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.
Diagnostic (specimen collection)	RNA analysis	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.
Diagnostic (specimen collection)	polymerase chain reaction	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.
Diagnostic (specimen collection)	gene expression analysis	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.

Primary Outcome Measures

Name	Time	Method
Performance of these models in predicting the likelihood of BCR	Visit 2 (intraoperative setting)	Logistic regression and artificial neural networks will be used.

Secondary Outcome Measures

Name	Time	Method
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery	Visit 2 (intraoperative setting)	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	Visit 2 (intraoperative setting)	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	Visit 2 (intraoperative setting)	Logistic regression and artificial neural networks will be used.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States