NCT03770351

Brief Summary

This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

4.5 years

First QC Date

December 3, 2018

Last Update Submit

April 7, 2021

Conditions

Prostate Cancer

Keywords

genomicsracial disparitiespatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Prostate-Cancer-specific change in quality of life

    Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite \[EPIC\] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.

    Day of enrollment, 6-months, and 12-months after enrollment

Secondary Outcomes (2)

  • Recurrence of cancer

    EMR data abstraction around the 6-month time point after enrollment

  • Complications of treatment

    EMR data abstraction around the 6-month time point after enrollment

Eligibility Criteria

Age18 Years - 90 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSince this study is working with prostate cancer, our cohort will only be males.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study population will be selected from clinics at 5 major southern California hospitals including: University of California, Irvine, University of California, Los Angeles, Cedars-Sinai Medical Center, Veterans Affair Healthcare Center Long Beach, and Veterans Affair Healthcare Center West Los Angeles.

You may qualify if:

  • years of age
  • Prostate-Specific Antigen (PSA) values \<50ng/ml
  • Clinical stage of T1 or T2
  • No evidence of metastasis or nodal involvement

You may not qualify if:

  • Age 91 or greater
  • Clinically locally advanced or metastatic disease
  • PSA equal to or greater than 50ng/ml
  • Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

Veterans Affair Long Beach Healthcare System

Long Beach, California, 90822, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Veterans Affair West Los Angeles Healthcare System

West Los Angeles, California, 90073, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

De-identified specimens stored.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sheldon Greenfield

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheldon Greenfield, M.D.

CONTACT

949-824-7286sgreenfi@uci.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 10, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for all primary and secondary outcome measures will be consolidated into one database and be made available to all participating research sites.

Shared Documents
SAP, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion
Access Criteria
Data access will only be allowed for the principal investigators from each research site.

Locations

US(5)