Clinical trial NCT03770351: Early Prostate Cancer: Predicting Treatment Response
Official title: Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: genomics
racial disparities
patient reported outcomes
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Cedars-Sinai Medical Center
name: VA Medical Center-West Los Angeles
name: VA Long Beach Healthcare System
First posted: 2018-12-10
Enrollment: 693
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prostate-Cancer-specific change in quality of life
timeFrame: Day of enrollment, 6-months, and 12-months after enrollment
Secondary outcomes:
measure: Recurrence of cancer
timeFrame: EMR data abstraction around the 6-month time point after enrollment
measure: Complications of treatment
timeFrame: EMR data abstraction around the 6-month time point after enrollment
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Long Beach
country: United States
facility: Veterans Affair Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: West Los Angeles
country: United States
facility: Veterans Affair West Los Angeles Healthcare System
state: California
Study officials:
affiliation: University of California, Irvine
name: Sheldon Greenfield
role: PRINCIPAL_INVESTIGATOR
References: