Early Prostate Cancer: Predicting Treatment Response

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770351
• Other study ID #: CIAPM [HS# 2017-3634]
• Status: Recruiting
• Start date: January 2017
• Est. completion date: July 2021

Study information

• Verified date: April 2021
• Source: University of California, Irvine
• Contact: Sheldon Greenfield, M.D.
• Phone: 949-824-7286
• Email: sgreenfi[@]uci.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 693
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	Veterans Affair Long Beach Healthcare System	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Veterans Affair West Los Angeles Healthcare System	West Los Angeles	California

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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