Early Prostate Cancer: Predicting Treatment Response

Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 693

Contacts and Locations

• Study Contact: Name: Sheldon Greenfield, M.D.; Phone Number: 949-824-7286; Email: sgreenfi@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • University of California, Irvine
    • Long Beach, California, United States, 90822
      • Recruiting
      • Veterans Affair Long Beach Healthcare System
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
    • West Los Angeles, California, United States, 90073
      • Recruiting
      • Veterans Affair West Los Angeles Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of cancer	Recurrence will be recorded from data abstraction from the electronic medical records (EMR).	EMR data abstraction around the 6-month time point after enrollment
Complications of treatment	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.	EMR data abstraction around the 6-month time point after enrollment

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, Los Angeles; Cedars-Sinai Medical Center; VA Long Beach Healthcare System; VA Medical Center-West Los Angeles
• Investigators: Principal Investigator: Sheldon Greenfield, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: genomics; patient reported outcomes; racial disparities
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CIAPM [HS# 2017-3634]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access will only be allowed for the principal investigators from each research site.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No