Clinical trial NCT03152448: Prospective Prolaris Value and Efficacy
Official title: Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prolaris
Prostate Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
Collaborators: name: VA Salt Lake City Health Care System
First posted: 2017-05-15
Enrollment: 1511
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting

Brief 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.

Detailed 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.

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 ng/dL 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

Primary outcomes:
measure: Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment
timeFrame: 6 months
measure: Prolaris prediction of biochemical or objective recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy
timeFrame: 5 years
measure: Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression
timeFrame: 5 years
measure: Association of Prolaris score with progression to active intervention when initially managed with AS or WW
timeFrame: 5 years
measure: Prognostic utility of Prolaris testing compared to other clinical pathological parameters with respect to disease progression in men who were Gleason score <7 on initial biopsy
timeFrame: 5 years
measure: Impact of Prolaris on magnitude of change between pre-Prolaris treatment selection and the post-Prolaris treatment plan following consultation with the patient
timeFrame: 3 months
measure: Impact of Prolaris on magnitude of change between physician likelihood of recommending non-interventional therapy and the likelihood following the genomic test results
timeFrame: 3 months
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital
state: Florida
city: Kansas City
country: United States
facility: Kansas City VAMC
state: Kansas
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Healtchare System
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis VA Healthcare System
state: Minnesota
city: Saint Louis
country: United States
facility: VA St. Louis Healthcare System
state: Missouri
city: Bronx
country: United States
facility: James J. Peters VA
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma City Veteran's Hospital
state: Oklahoma
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
city: Houston
country: United States
facility: Michael E. DeBakey VAMC
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
Study officials:
References: