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

City of Hope

Status and phase: Active, not recruiting; Phase 1

Conditions: Prostate Cancer

Treatments: Other: diagnostic laboratory biomarker analysis; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: RNA analysis; Genetic: DNA methylation analysis; Genetic: DNA analysis; Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00977457

CDR0000644208 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

CHNMC-06072

06072

NCI-2011-00980 (Registry Identifier)

5R01CA102521 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,045 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,045 participants in 1 patient group

Diagnostic (specimen collection)

Experimental group

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.

Treatment:

Procedure: therapeutic conventional surgery

Genetic: DNA analysis

Genetic: RNA analysis

Genetic: DNA methylation analysis

Other: diagnostic laboratory biomarker analysis

Genetic: polymerase chain reaction

Genetic: gene expression analysis