Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer

Stopped early

Conditions studied: Prostate Cancer

In brief

This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.

Key facts

Study ID

NCT03290508

Run by

Myriad Genetic Laboratories, Inc.

People needed

524

Starts

2017-09-14

Expected to finish

2022-01-14

Last updated by the study team

2022-06-23

Who can join

Age: 65 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
• Willing to provide written informed consent.
• Males ≥65 years old.
• Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
• Candidate for and considering AS and yet would be eligible for definitive therapy.
• Favorable intermediate-risk disease, defined by the NCCN as follows:
• predominant Gleason grade 3; AND
• percentage of positive cores <50%; AND
• no more than 1 of the following NCCN intermediate-risk factors:
• Gleason grade 7
• T2b-T2c
• PSA 10-20 ng/mL
• Estimated life expectancy ≥10 years.
• Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

You may not qualify if…

• 1. Clinical evidence of metastasis or lymph node involvement.
• 2. Received pelvic radiation prior to biopsy.
• 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
• 4. Participation in interventional clinical trials.
• 5. Patient is considering watchful waiting.
• 6. Has a known history of hypogonadism.

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• East Valley Urology Center — Mesa, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• Pacific Urology — Concord, California, United States
• VA Long Beach Healthcare — Long Beach, California, United States
• UCI Medical Center — Orange, California, United States
• Ssg Md Apc — San Jose, California, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Urology Group of Florida — Delray Beach, Florida, United States
• Pinellas Urology — St. Petersburg, Florida, United States
• 21st Century Oncology — Sunrise, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• URO Partners — Westchester, Illinois, United States
• Wichita Urology — Wichita, Kansas, United States
• Regional Urology — Shreveport, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan, Department of Urologic Oncology — Ann Arbor, Michigan, United States
• Comprehensive Urology — Royal Oak, Michigan, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• UroLogic — Tupelo, Mississippi, United States
• Premier Urology Group, LLC — Cranford, New Jersey, United States
• Premier Urology — Cranford, New Jersey, United States
• Urologic Research and Consulting LLC — Englewood, New Jersey, United States

Full record on ClinicalTrials.gov

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