NCT01376661

Brief Summary

The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

7.3 years

First QC Date

June 3, 2011

Last Update Submit

March 30, 2021

Conditions

Prostate Cancer

Keywords

Prostate CancerActive SurveillanceLow risk prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of enrolled subjects who remain compliant free until disease progression.

    This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer

    10 years

Secondary Outcomes (4)

  • Percentage of enrolled subjects who require definitive therapy

    10 years

  • Quality of Life as measured by patient survey.

    10 Years

  • Overall survival

    10 years

  • Cost/Benefit Analysis

    10 Years

Study Arms (1)

Active Surveillance/ Prostate Cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with low risk prostate cancer.

You may qualify if:

  • At least 18 years of age
  • Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
  • PSA \< 10 ng/ml within 1 month of program enrollment
  • Clinical stage less than or equal to T2a
  • Biopsy sampling with at least 10-12 cores
  • Gleason score less than or equal to 3 + 3
  • No more than 2 cores involved
  • No core more than 50% involved
  • Eligible for definitive therapy
  • Able to provide informed consent
  • Able to complete a QOL questionnaire
  • Able to comply with the scheduled follow-up appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Hospital of Orange

Orange, California, 92868, 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

  • Matthew Greenberger, MD

    St. Joseph Hospital of Orange

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 20, 2011

Study Start

May 1, 2009

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 2, 2021

Record last verified: 2021-03

Locations

US(1)