Prostate Cancer Clinical Trial

Prospective Prolaris Value and Efficacy

Summary

This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.

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Full Description

This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.

PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.

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Eligibility Criteria

Inclusion Criteria:

Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
Clinically localized (no evidence on clinical or imaging studies of advanced disease)
No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
Sufficient amount of tissue remains from biopsy to perform genomic testing
Life expectance of a minimum of 10 years
Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.

Exclusion Criteria:

Men with clinical node positive or metastatic disease
Men with a known baseline total serum testosterone level of <100 ngdL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
Men who previously received pelvic radiotherapy for another malignancy
Non adenocarcinoma prostate cancer histologies

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1511

Study ID:

NCT03152448

Recruitment Status:

Terminated

Sponsor:

Myriad Genetic Laboratories, Inc.

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There are 12 Locations for this study

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VA San Diego Healthcare System
San Diego California, 92161, United States
VA Connecticut Healthcare System
West Haven Connecticut, 06516, United States
James A. Haley Veterans' Hospital
Tampa Florida, 33612, United States
Kansas City VAMC
Kansas City Kansas, 64128, United States
Southeast Louisiana Veterans Healtchare System
New Orleans Louisiana, 70112, United States
Minneapolis VA Healthcare System
Minneapolis Minnesota, 55417, United States
VA St. Louis Healthcare System
Saint Louis Missouri, 63106, United States
James J. Peters VA
Bronx New York, 10468, United States
Oklahoma City Veteran's Hospital
Oklahoma City Oklahoma, 73104, United States
Ralph H. Johnson VAMC
Charleston South Carolina, 29401, United States
Michael E. DeBakey VAMC
Houston Texas, 77030, United States
Salt Lake City VA Medical Center
Salt Lake City Utah, 84148, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1511

Study ID:

NCT03152448

Recruitment Status:

Terminated

Sponsor:


Myriad Genetic Laboratories, Inc.

How clear is this clinincal trial information?

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