Early Prostate Cancer: Predicting Treatment Response

University of California Irvine (UCI)

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03770351

CIAPM [HS# 2017-3634]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 693 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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