Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT03770351

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT03770351

Start date

Jan, 2017

Status verified date

Apr, 2021

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

693 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prostate-Cancer-specific change in quality of life [ Time Frame: Day of enrollment, 6-months, and 12-months after enrollment ]

Central Contacts and Locations

Central contacts

Sheldon Greenfield, M.D.

949-824-7286sgreenfi@uci.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Veterans Affair Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Veterans Affair West Los Angeles Healthcare System

Recruiting

West Los Angeles, California, United States, 90073

More Information

Sponsor

University of California, Irvine

Last update posted

Apr 9, 2021

Last verified

Apr, 2021

Keywords

  • genomics
  • racial disparities
  • patient reported outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2021-04-09.