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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

Tracking Information
First Submitted Date December 3, 2018
First Posted Date December 10, 2018
Last Update Posted Date April 9, 2021
Actual Study Start Date January 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 6, 2018)
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Prostate Cancer: Predicting Treatment Response
Official Title Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
De-identified specimens stored.
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.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 20, 2019)
693
Original Estimated Enrollment
 (submitted: December 6, 2018)
600
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
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.
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sheldon Greenfield, M.D. 949-824-7286 sgreenfi@uci.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03770351
Other Study ID Numbers CIAPM [HS# 2017-3634]
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Current Responsible Party University of California, Irvine
Original Responsible Party Sheldon Greenfield, University of California, Irvine, Donald Bren Professor of Medicine
Current Study Sponsor University of California, Irvine
Original Study Sponsor Same as current
Collaborators
  • 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
PRS Account University of California, Irvine
Verification Date April 2021