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

  • STATUS
    Recruiting
  • End date
    Sep 23, 2027
  • participants needed
    6000
  • sponsor
    Myriad Genetic Laboratories, Inc.
Updated on 23 December 2019
Investigator
Bryan Dechairo, PhD
Primary Contact
Pacific Urology (8.8 mi away) Contact
+39 other location
adenocarcinoma
adenocarcinoma of prostate

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.

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.

Details
Treatment Prolaris Testing
Clinical Study IdentifierNCT03290508
SponsorMyriad Genetic Laboratories, Inc.
Last Modified on23 December 2019

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Are you male?
Do you have Malignant neoplasm of prostate?
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-nave 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 6\. Estimated life expectancy 10 years. 7\. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines)

Exclusion Criteria

\. Clinical evidence of metastasis or lymph node involvement
\. Received pelvic radiation prior to biopsy
\. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted
\. Participation in interventional clinical trials
\. Patient is considering watchful waiting
\. Has a known history of hypogonadism
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