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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Prolaris Testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolaris Testing<br>Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing | Diagnostic Test: Prolaris Testing<br>* Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing<br>* Other names: RNA expression signature of cell cycle progression genes;|
| No Prolaris Testing<br>Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Prolaris Score, on Active Surveillance | Proportion of patients with low Prolaris scores who are initially treated with active surveillance | 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 | 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. | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 years | 
| No Prolaris Score, on Active Surveillance | Proportion of patients without Prolaris testing who are initially treated with active surveillance. | 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. | 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. | 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. | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolaris, Prostate Cancer, Cell Cycle Progression Test