NCT01326286

Brief Summary

This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

6.4 years

First QC Date

March 25, 2011

Last Update Submit

September 24, 2018

Conditions

Prostate Cancer

Keywords

Comparative Effectiveness ResearchProstatectomyradiotherapyquality of life

Outcome Measures

Primary Outcomes (1)

  • Disease-Specific Health-Related Quality of Life (EPIC)

    Sexual, urinary, bowel and hormonal function and bother subscores will be assessed

    12, 24 and 60 months after enrollment

Secondary Outcomes (3)

  • cancer-free survival

    6 and 12 months after enrollment

  • Complications of treatment

    6- and 12-months after enrollment

  • General Health-Related Quality of Life (SF-12)

    6- and 12-months after enrollment

Study Arms (7)

Open Radical Prostatectomy

262

Robotic Radical Prostatectomy

1303

Intensity-Modulated Radiotherapy

638

Interstitial Brachytherapy

171

combined EBRT and Brachytherapy

143

Active Surveillance

448

Various other treatments

300

Eligibility Criteria

Age18 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population-based sample of men diagnosed with localized prostate cancer in the states of Louisiana and New Jersey and the metropolitan areas of Atlanta and Los Angeles, augmented with a convenience sample of men enrolled in the CaPSURE database, a national observational disease registry.

You may qualify if:

  • Pathologic diagnosis of adenocarcinoma of the prostate
  • Clinically localized stage
  • PSA \<50ng/ml
  • age 18-79

You may not qualify if:

  • diagnosis of other malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
  • age 80 or greater
  • clinically locally advanced or metastatic disease
  • PSA equal to or greater than 50 ng/ml
  • pathologic diagnosis of prostate cancer greater than 6 months prior to baseline recruitment interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Lousiana State University Health Sciences Center- New Orleans

New Orleans, Louisiana, 70112, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • David F Penson, MD, MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urologic Surgery

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 30, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2017

Study Completion

September 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

US(5)