An observational study in Prostate Cancer, sponsored by Myriad Genetic Laboratories, Inc.. Terminated at 34 sites in United States. Open to male participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Myriad Genetic Laboratories, Inc. · Observational
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.
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.
Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk localized prostate cancer whose initial treatment has not been decided and who are being seen at Medicare Certification and Training Registry (CTR) practices in the United States.
Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
Favorable intermediate-risk disease, defined by the NCCN as follows:
no more than 1 of the following NCCN intermediate-risk factors:
Exclusion Criteria:
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
Diagnostic Test: Prolaris Testing
Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
Also known as: RNA expression signature of cell cycle progression genes
Low Prolaris Score, on Active Surveillance
Proportion of patients with low Prolaris scores who are initially treated with active surveillance
Time frame: 3 years
Low Prolaris Score, Definitive Treatment Following Active Surveillance
Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
Time frame: 3 years
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.
Time frame: 8 years
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.
Time frame: 8 years
No Prolaris Score, on Active Surveillance
Proportion of patients without Prolaris testing who are initially treated with active surveillance.
Time frame: 3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance
Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.
Time frame: 3 years
No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.
Time frame: 8 years
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.
Time frame: 8 years
Plan to share: Yes — Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Myriad Genetic Laboratories, Inc.