Prospective Prolaris Value and Efficacy



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/8/2018
Start Date:September 1, 2015
End Date:January 2024
Contact:Todd Cohen, MD
Email:tcohen@myriad.com

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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

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.

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.

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
We found this trial at
12
sites
Minneapolis, Minnesota 55417
Principal Investigator: Michael Risk, MD
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Bronx, New York 10468
Principal Investigator: Christopher Anderson, MD
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Bronx, NY
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Charleston, South Carolina 29403
Principal Investigator: Stephen J. Savage, MD
Phone: 843-792-5787
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Charleston, SC
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2002 Holcombe Boulevard
Houston, Texas 77030
Principal Investigator: Jeffrey A. Jones, MD
Phone: 713-798-4001
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Houston, TX
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Kansas City, Kansas 64128
Principal Investigator: Sharad Mathur, MD
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Kansas City, KS
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New Orleans, Louisiana 70112
Principal Investigator: Jonathan Silberstein, MD
Phone: 504-988-0768
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New Orleans, LA
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Oklahoma City, Oklahoma 73104
Principal Investigator: Kelly Stratton, MD
Phone: 405-271-6900
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Oklahoma City, OK
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Saint Louis, Missouri 63106
Principal Investigator: Ralph Torrence, MD
Phone: 314-652-4700
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Saint Louis, MO
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500 Foothill Drive
Salt Lake City, Utah 84148
Principal Investigator: William T. Lowrance, MD, MPH
Phone: 801-587-4282
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Salt Lake City, UT
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3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
Principal Investigator: Kyoko Sakamoto, MD
Phone: 858-642-3407
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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San Diego, CA
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Tampa, Florida 33637
Principal Investigator: Cesar Ercole, MD
Phone: 813-972-2000
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Tampa, FL
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950 Campbell Ave
West Haven, Connecticut 06516
(203) 932-5711
Principal Investigator: Preston Sprenkle, MD
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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West Haven, CT
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