Prolaris Testing for Prostate Cancer

Not currently recruiting at 6 trial locations

Overseen By Thaylon Davis

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Myriad Genetic Laboratories, Inc.

Must not be taking: Androgen deprivation therapy

Disqualifiers: Metastasis, Lymph node involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how men with newly diagnosed, localized prostate cancer choose treatments after receiving Prolaris testing, a genetic test that assesses cancer aggressiveness. Researchers aim to determine how many men opt for active surveillance (monitoring the cancer closely without immediate treatment), how long they continue with it, and their health outcomes over time. Men diagnosed with localized prostate cancer in the last six months who have undergone Prolaris testing may be suitable for this study. As an unphased study, this trial allows participants to contribute to understanding treatment choices and outcomes in prostate cancer management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does allow the use of 5 alpha-reductase inhibitors (a type of medication for prostate issues).

What prior data suggests that Prolaris® Testing is safe?

Research has shown that Prolaris® is a genomic test that aids in deciding treatment options for prostate cancer. This test analyzes changes in 46 genes from prostate tissue to generate a risk score, predicting how the cancer might progress.

Regarding safety, a study examined the safety of using genomic tests like Prolaris® to guide treatment decisions in prostate cancer patients. The results indicated that using this test to decide on treatments, such as active surveillance (monitoring the cancer without immediate treatment), is safe. No harmful effects from the test itself were reported.

It is important to understand that Prolaris® is not a treatment but a test that informs treatment decisions. Therefore, it does not carry the same safety concerns as a drug or surgery. Instead, it provides valuable information to help doctors and patients choose the best plan for managing prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate cancer, which often focus on surgery, radiation, or hormone therapy, Prolaris® Testing is all about understanding how aggressive the cancer might be. Researchers are excited about this test because it measures the activity level of certain genes in the cancer cells, giving a clearer picture of how quickly the cancer is likely to grow and spread. This insight can help doctors tailor treatment plans more precisely, potentially sparing patients from unnecessary aggressive treatments and their side effects. In essence, Prolaris® offers a personalized approach to treatment planning that could lead to better outcomes and a better quality of life for patients.

What evidence suggests that Prolaris® Testing is effective for treatment selection in prostate cancer?

Research has shown that Prolaris testing effectively predicts the progression of prostate cancer. Studies have found that it enhances prognosis accuracy, particularly for patients with low- or intermediate-grade prostate cancer. The test assesses the risk of cancer worsening, aiding in treatment decisions. The National Comprehensive Cancer Network (NCCN) endorses Prolaris as an essential tool for predicting prostate cancer outcomes. It has been tested across various patient groups and clinical settings, consistently offering valuable insights into the disease's likely development. ^{3 6 7 8 9}

Who Is on the Research Team?

Walter Rayford, M.D.

Principal Investigator

The Urology Group

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.

Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.

Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline clinicopathologic measures, including pre-biopsy PSA, date of biopsy, prostate volume, biopsy findings, total number of biopsy cores, number of positive cores, clinical stage, Gleason score, NCCN risk category, and Prostate MRI assessment results

Baseline

Active Surveillance

Participants select Active Surveillance or definitive therapy following Prolaris testing, with monitoring of disease progression and comorbidities

Up to 10 years

Annual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease progression and reclassification

Up to 10 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Prolaris® Testing

Who Is Running the Clinical Trial?

Myriad Genetic Laboratories, Inc.

Lead Sponsor

Trials

32

Recruited

14,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03511235

Clinical Outcomes in Men With Prostate Cancer Who ... This study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria ...

2. targetedonc.com targetedonc.com/view/nccn-reinforces-prolaris-value-in-predicting-prostate-cancer-outcomes

NCCN Reinforces Prolaris' Value in Predicting Prostate ... The NCCN has endorsed the Prolaris prostate cancer prognostic test, reinforcing its position as a critical tool in prostate cancer prognostication.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10961791/

Tissue-Based Genomic Testing in Prostate Cancer Tissue-based genomic testing in prostate cancer: 10-year analysis of national trends on the use of prolaris, decipher, promark, and oncotype DX.

4. aafp.org aafp.org/pubs/afp/issues/2019/0901/p311.html

Prolaris Test for Prostate Cancer Risk Assessment The Prolaris test improves the accuracy of prognosis for patients with prostate cancer, especially those with low- or intermediate-grade ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT113194

Prolaris: A novel genetic test for prostate cancer prognosis. Conclusions: The Prolaris test predicts prostate cancer outcome in multiple patient cohorts and diverse clinical settings. In all cases, it provides ...

6. myriad.com myriad.com/prolaristest/

Prolaris® Prostate Cancer Genomic Test Discover how the Prolaris® Test helps personalize treatment for intermediate-risk prostate cancer and support confident active surveillance decisions.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.336

Safety and clinical validity of tumor genomic testing for ... This study evaluated the safety of genomic testing for guiding AS selection in patients with National Comprehensive Cancer Network (NCCN) intermediate-risk PCa.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01954004

Open Registry Measuring Impact of Genomic Testing on ... This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate ...

9. prolaris-result.com prolaris-result.com/html/downloads/IFU_Prolaris%20QS5%20Dx_EN.pdf

Prolaris® for QuantStudio™ 5 Dx Instruction Manual Warning notes and additional information about the reagents can be found in the material safety data sheets, which are available upon request from Eurobio ...