Prospective Prolaris Value and Efficacy

Stopped early

Conditions studied: Prostate Cancer

In brief

This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.

Key facts

Study ID

NCT03152448

Run by

Myriad Genetic Laboratories, Inc.

People needed

1511

Starts

2015-09-01

Expected to finish

2022-03-21

Last updated by the study team

2022-06-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
• Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
• Clinically localized (no evidence on clinical or imaging studies of advanced disease)
• No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
• Sufficient amount of tissue remains from biopsy to perform genomic testing
• Life expectance of a minimum of 10 years
• Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.

You may not qualify if…

• Men with clinical node positive or metastatic disease
• Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
• Men who previously received pelvic radiotherapy for another malignancy
• Non adenocarcinoma prostate cancer histologies

Where it is running

• VA San Diego Healthcare System — San Diego, California, United States
• VA Connecticut Healthcare System — West Haven, Connecticut, United States
• James A. Haley Veterans' Hospital — Tampa, Florida, United States
• Kansas City VAMC — Kansas City, Kansas, United States
• Southeast Louisiana Veterans Healtchare System — New Orleans, Louisiana, United States
• Minneapolis VA Healthcare System — Minneapolis, Minnesota, United States
• VA St. Louis Healthcare System — St Louis, Missouri, United States
• James J. Peters VA — The Bronx, New York, United States
• Oklahoma City Veteran's Hospital — Oklahoma City, Oklahoma, United States
• Ralph H. Johnson VAMC — Charleston, South Carolina, United States
• Michael E. DeBakey VAMC — Houston, Texas, United States
• Salt Lake City VA Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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