Prostate Cancer Clinical Trial

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

Summary

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.

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Full Description

This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.

Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

524

Study ID:

NCT03290508

Recruitment Status:

Terminated

Sponsor:

Myriad Genetic Laboratories, Inc.

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There are 33 Locations for this study

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Urology Centers of Alabama
Homewood Alabama, 35209, United States
East Valley Urology Center
Mesa Arizona, 85206, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
Pacific Urology
Concord California, 94520, United States
VA Long Beach Healthcare
Long Beach California, 90822, United States
UCI Medical Center
Orange California, 92866, United States
Ssg Md Apc
San Jose California, 95124, United States
Advanced Urology Institute
Daytona Beach Florida, 32114, United States
Urology Group of Florida
Delray Beach Florida, 33484, United States
Pinellas Urology
Saint Petersburg Florida, 33710, United States
21st Century Oncology
Sunrise Florida, 33351, United States
Meridian Clinical Research
Savannah Georgia, 31405, United States
North Idaho Urology
Coeur d'Alene Idaho, 83814, United States
URO Partners
Westchester Illinois, 60154, United States
Wichita Urology
Wichita Kansas, 67226, United States
Regional Urology
Shreveport Louisiana, 71106, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
University of Michigan, Department of Urologic Oncology
Ann Arbor Michigan, 48109, United States
Comprehensive Urology
Royal Oak Michigan, 48073, United States
Michigan Institute of Urology
Troy Michigan, 48084, United States
UroLogic
Tupelo Mississippi, 38801, United States
Premier Urology Group, LLC
Cranford New Jersey, 07016, United States
Premier Urology
Cranford New Jersey, 07016, United States
Urologic Research and Consulting LLC
Englewood New Jersey, 07631, United States
Stony Brook University
Stony Brook New York, 11794, United States
A.M.P. Radiation Oncology
Syracuse New York, 13210, United States
Associated Urologists of North Carolina
Raleigh North Carolina, 27612, United States
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Carolina Urology Partners
West Columbia South Carolina, 29163, United States
Urology Associates
Nashville Tennessee, 37209, United States
Rio Grande Urology
El Paso Texas, 79912, United States
Seattle Urology Research Center
Burien Washington, 98166, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

524

Study ID:

NCT03290508

Recruitment Status:

Terminated

Sponsor:


Myriad Genetic Laboratories, Inc.

How clear is this clinincal trial information?

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