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Early Prostate Cancer: Predicting Treatment Response

Sponsor
University of California, Irvine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03770351
Collaborator
University of California, Los Angeles (Other), Cedars-Sinai Medical Center (Other), VA Medical Center-West Los Angeles (U.S. Fed), VA Long Beach Healthcare System (U.S. Fed)
693
Enrollment
5
Locations
53.9
Anticipated Duration (Months)
138.6
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will contribute a replicable model for improving risk prediction from patient characteristics, clinical severity indicators, and genomic tests to aid in personalizing treatment. The proposed registry would also allow future comparisons of the gene expression used in other competing commercial test. The addition of the suggested genomic classifier and its associations with other patient and clinical characteristics will enhance the ability of future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness in prostate cancer.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    693 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2021
    Anticipated Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Prostate-Cancer-specific change in quality of life [Day of enrollment, 6-months, and 12-months after enrollment]

      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.

    Secondary Outcome Measures

    1. Recurrence of cancer [EMR data abstraction around the 6-month time point after enrollment]

      Recurrence will be recorded from data abstraction from the electronic medical records (EMR).

    2. Complications of treatment [EMR data abstraction around the 6-month time point after enrollment]

      Complications of treatment will be measured using general scales for identifying complications and severity (the Clavien system) as well as assessment of a priori identified complications that are known to occur with prostate cancer care. This information will be collected from electronic medical records.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 - 90 years of age

    • Prostate-Specific Antigen (PSA) values <50ng/ml

    • Clinical stage of T1 or T2

    • No evidence of metastasis or nodal involvement

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Irvine Irvine California United States 92697
    2 Veterans Affair Long Beach Healthcare System Long Beach California United States 90822
    3 Cedars-Sinai Medical Center Los Angeles California United States 90048
    4 University of California, Los Angeles Los Angeles California United States 90095
    5 Veterans Affair West Los Angeles Healthcare System West Los Angeles California United States 90073

    Sponsors and Collaborators

    • University of California, Irvine
    • University of California, Los Angeles
    • Cedars-Sinai Medical Center
    • VA Medical Center-West Los Angeles
    • VA Long Beach Healthcare System

    Investigators

    • Principal Investigator: Sheldon Greenfield, University of California, Irvine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Irvine
    ClinicalTrials.gov Identifier:
    NCT03770351
    Other Study ID Numbers:
    • CIAPM [HS# 2017-3634]
    First Posted:
    Dec 10, 2018
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, Irvine
    genomics
    racial disparities
    patient reported outcomes
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 9, 2021