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Early Prostate Cancer: Predicting Treatment Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770351
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
University of California, Los Angeles
Cedars-Sinai Medical Center
VA Medical Center-West Los Angeles
VA Long Beach Healthcare System
Information provided by (Responsible Party):
University of California, Irvine

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
Prostate Cancer

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 693 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Prostate-Cancer-specific change in quality of life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
De-identified specimens stored.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since this study is working with prostate cancer, our cohort will only be males.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770351


Contacts
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Contact: Sheldon Greenfield, M.D. 949-824-7286 sgreenfi@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Veterans Affair Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Veterans Affair West Los Angeles Healthcare System Recruiting
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
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Principal Investigator: Sheldon Greenfield University of California, Irvine
Additional Information:

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03770351    
Other Study ID Numbers: CIAPM [HS# 2017-3634]
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases