Early Prostate Cancer: Predicting Treatment Response

• Conditions: Prostate Cancer

• Registration Number: NCT03770351
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-09
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 693

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.

Trial Locations

Locations (5)

Veterans Affair West Los Angeles Healthcare System; 🇺🇸 West Los Angeles, California, United States

Veterans Affair Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States