Purpose

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.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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-naïve 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
  • Estimated life expectancy ≥10 years.
  • Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Exclusion Criteria

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Prolaris Testing Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
  • Diagnostic Test: Prolaris Testing
    Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
    Other names:
    • RNA expression signature of cell cycle progression genes
No Prolaris Testing Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing

Recruiting Locations

Urology Centers of Alabama
Homewood, Alabama 35209
Contact:
Stacey Morgan
205-445-0124
smorgan@urologyal.com

East Valley Urology Center
Mesa, Arizona 85206
Contact:
Justina Burrell

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Rachel Jones
501-686-8274
RJones3@uams.edu

Arkansas Urology
Little Rock, Arkansas 72211
Contact:
Katie O'Brian
501-319-2221
katie@arkansasurology.com

VA Long Beach Healthcare
Long Beach, California 90822
Contact:
Katherine Isip
562-826-8000
Katherine.isip@va.gov

UCI Medical Center
Orange, California 92866
Contact:
Nyles Oune
714-456-8131
nyleso@uci.edu

Ssg Md Apc
San Jose, California 95124
Contact:
Lisa Kody
408-358-2030
lisa@uasv.com

Advanced Urology Institute
Daytona Beach, Florida 32114
Contact:
Jonelle J Horsley
386-239-8535
jonelle.horsley@auihealth.com

Urology Group of Florida
Delray Beach, Florida 33484
Contact:
Anne Crane
561-245-1456
ann@ausfl.com

Pinellas Urology
Saint Petersburg, Florida 33710
Contact:
Pallavi Purohit
727-381-8667
ppurohit@uswfllp.com

21st Century Oncology
Sunrise, Florida 33351
Contact:
Peggy Mouradian
954-370-7555
Peggy.Mouradian@21co.com

Meridian Clinical Research
Savannah, Georgia 31405
Contact:
Taryn Collett
912-790-4837
tcollett@mcrmed.com

URO Partners
Westchester, Illinois 60154
Contact:
Celeste Ruiz
708-273-3735
cruiz@uropartners.com

Wichita Urology
Wichita, Kansas 67226
Contact:
Kristine Wheeler
316-636-6141
kwheeler@wichitaurology.com

Regional Urology
Shreveport, Louisiana 71106
Contact:
Leah Renfro
318-683-0411
lrenfro@regionalurology.com

University of Michigan, Department of Urologic Oncology
Ann Arbor, Michigan 48109
Contact:
Steven Thelen-Perry
perryste@med.umich.edu

Comprehensive Urology
Royal Oak, Michigan 48073
Contact:
Bridget Makhlouf
248-336-1096
BMakhlouf@urologist.org

Michigan Institute of Urology
Troy, Michigan 48084
Contact:
Danielle Osterhout
248-786-0467
OsterhoutD@michiganurology.com

Premier Urology Group, LLC
Cranford, New Jersey 07016
Contact:
Colleen Palomino
201-936-2526
cpalomino@premierurologygroup.com

Premier Urology
Cranford, New Jersey 07016
Contact:
Colleen Palomino
201-936-2526
cpalomino@premierurologygroup.com

Stony Brook University
Stony Brook, New York 11794
Contact:
Audrey Anderson
631-638-0845
Audrey.Anderson@stonybrookmedicine.edu

A.M.P. Radiation Oncology
Syracuse, New York 13210
Contact:
Sarah Faisal
315-478-4185
sfaisal@ampofny.com

Associated Urologists of North Carolina
Raleigh, North Carolina 27612
Contact:
Jan Vickerson
919-390-7354
jvickerson@gmail.com

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
Contact:
Lois Reidenbach
610-402-9151
Lois_M.Reidenbach@lvhn.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Mike Wheeler
843-792-8625
wheelerm@musc.edu

Carolina Urology Partners
West Columbia, South Carolina 29163
Contact:
Kristin Kennedy
704-414-2870
kristin.kennedy@carolinaurology.com

Urology Associates
Nashville, Tennessee 37209
Contact:
Rick Trotter
615-250-9268
crtrotter@ua-pc.com

Rio Grande Urology
El Paso, Texas 79912
Contact:
Stephen Voglewede
915-539-8798
svoglewede@gmail.com

Seattle Urology Research Center
Burien, Washington 98166
Contact:
Angel Filipa
206-243-3701
surc@comcast.net

More Details

NCT ID
NCT03290508
Status
Recruiting
Sponsor
Myriad Genetic Laboratories, Inc.

Study Contact

Bryan Dechairo, PhD
801-584-1134
bryan.dechairo@myriad.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.