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.
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.
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.
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There are 33 Locations for this study
Homewood Alabama, 35209, United States
Mesa Arizona, 85206, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72211, United States
Concord California, 94520, United States
Long Beach California, 90822, United States
Orange California, 92866, United States
San Jose California, 95124, United States
Daytona Beach Florida, 32114, United States
Delray Beach Florida, 33484, United States
Saint Petersburg Florida, 33710, United States
Sunrise Florida, 33351, United States
Savannah Georgia, 31405, United States
Coeur d'Alene Idaho, 83814, United States
Westchester Illinois, 60154, United States
Wichita Kansas, 67226, United States
Shreveport Louisiana, 71106, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48084, United States
Tupelo Mississippi, 38801, United States
Cranford New Jersey, 07016, United States
Cranford New Jersey, 07016, United States
Englewood New Jersey, 07631, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Raleigh North Carolina, 27612, United States
Allentown Pennsylvania, 18103, United States
Charleston South Carolina, 29425, United States
West Columbia South Carolina, 29163, United States
Nashville Tennessee, 37209, United States
El Paso Texas, 79912, United States
Burien Washington, 98166, United States
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