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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,045

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline

2mo left

Started Nov 2007

Longer than P75 for phase_1 prostate-cancer

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

18.6 years study duration

Study Progress99%

Nov 2007Jul 2026

Study Start

First participant enrolled

November 26, 2007

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2016

Completed

10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2026

Expected

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8.6 years

First QC Date

September 12, 2009

Last Update Submit

August 18, 2025

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
Visit 2 (intraoperative setting)
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
Visit 2 (intraoperative setting)
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens
Visit 2 (intraoperative setting)

Study Arms (1)

Diagnostic (specimen collection)

EXPERIMENTAL

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 analysisGenetic: DNA methylation analysisGenetic: RNA analysisGenetic: gene expression analysisGenetic: polymerase chain reactionOther: diagnostic laboratory biomarker analysisProcedure: therapeutic conventional surgery

Interventions

DNA analysisGENETIC

Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery