Outcome Assessment of an Active Surveillance Program for... | NCT01376661

Studies
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

NCT01376661

Sponsor

St. Joseph Hospital of Orange

Status

Terminated

Last Update Posted

Apr 2, 2021Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Early termination due to PI's decision to discontinue research activities.

Expanded Access Info

Start Date

May 2009Actual

Primary Completion Date

Sep 1, 2016Actual

Completion Date

Sep 1, 2016Actual

First Submitted Date

Jun 3, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2021

Last Update Posted Date

Apr 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
Active Surveillance/ Prostate Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percentage of enrolled subjects who require definitive therapy		10 years
Quality of Life as measured by patient survey.		10 Years
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

See inclusion criteria for eligibility

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Men with low risk prostate cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Greenberger, MD	St. Joseph Hospital of Orange	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph Hospital of Orange		Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided