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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence

Conditions
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Prostate Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (specimen collection)<br>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<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Genetic: DNA methylation analysis<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Genetic: RNA analysis<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Genetic: gene expression analysis<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Genetic: polymerase chain reaction<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Other: diagnostic laboratory biomarker analysis<br>* Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery<br>Procedure: therapeutic conventional surgery<br> <br> * Other names: Undergo robotic prostatectomy or cystoprostatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of these models in predicting the likelihood of BCR | Logistic regression and artificial neural networks will be used. | Visit 2 (intraoperative setting) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery | Logistic regression and artificial neural networks will be used. | Visit 2 (intraoperative setting) | 
| 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. | Visit 2 (intraoperative setting) | 
| 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. | Visit 2 (intraoperative setting) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer