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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:3/6/2019
Start Date:September 14, 2017
End Date:September 2027
Contact:Bryan Dechairo, PhD
Email:bryan.dechairo@myriad.com
Phone:801-584-1134

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Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)

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.

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.

Inclusion Criteria:

- Patients who have undergone CCP testing and patients who have not undergone CCP
testing will be considered for enrollment in the study.

1. Willing to provide written informed consent.

2. Males ≥65 years old.

3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven
localized adenocarcinoma of prostate whose initial treatment has not been
decided.

4. Candidate for and considering AS and yet would be eligible for definitive
therapy.

5. 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:

- 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.
We found this trial at
36
sites
Middleburg Heights, Ohio 44130
Principal Investigator: Lawrence Gervasi, MD
Phone: 440-305-8151
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Allentown, Pennsylvania 18105
Principal Investigator: Angelo Baccala, MD
Phone: 610-402-9151
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Ann Arbor, Michigan 48109
Principal Investigator: Todd Morgan, MD
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Baltimore, Maryland 21204
Principal Investigator: Anup Shah, MD
Phone: 443-471-5749
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Baltimore, MD
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Burien, Washington 98166
Principal Investigator: Jeffrey Frankel, MD
Phone: 206-243-3701
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Burien, WA
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Coeur d'Alene, Idaho 83814
Principal Investigator: Chad Peterson, MD
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2222 East Street
Concord, California 94520
Principal Investigator: Jeremy Lieb, MD
Phone: 925-609-7220
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Concord, CA
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Cranford, New Jersey 07016
Principal Investigator: Andrew Bernstein, MD
Phone: 201-936-2526
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Cranford, NJ
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Cranford, New Jersey 07016
Principal Investigator: Andrew Bernstein, MD
Phone: 201-936-2526
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545 Health Boulevard
Daytona Beach, Florida 32114
Principal Investigator: Michael S Grable, MD
Phone: 386-239-8535
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Delray Beach, Florida 33484
Principal Investigator: Lawrence Yore, MD
Phone: 561-245-1456
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El Paso, Texas 79912
Principal Investigator: Daniel Voglewede, MD
Phone: 915-539-8798
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300 Grand Avenue
Englewood, New Jersey 07631
Principal Investigator: Eric Margolis, MD
Phone: 201-510-3178
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Englewood, NJ
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Federal Way, Washington 98003
Principal Investigator: Ken Haberman, MD
Phone: 253-927-1882
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Federal Way, WA
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Homewood, Alabama 35209
Principal Investigator: Austin Lutz, MD
Phone: 205-445-0124
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Lancaster, Pennsylvania 17604
Principal Investigator: Paul Sieber, MD
Phone: 717-431-2282
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Little Rock, Arkansas 72211
Principal Investigator: Richard D'Anna, MD
Phone: 501-319-2221
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Long Beach, California 90822
Principal Investigator: Edward Uchio, MD
Phone: 562-826-8000
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Mesa, Arizona 85206
Principal Investigator: Rahul Mehan, MD
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Nashville, Tennessee 37209
Principal Investigator: David Morris, MD
Phone: 615-250-9268
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Poughkeepsie, New York 12601
Principal Investigator: Evan Goldfischer, MD
Phone: 845-437-3804
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Raleigh, North Carolina 27607
Principal Investigator: Mark Jalkut, MD
Phone: 919-390-7354
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Royal Oak, Michigan 48067
Principal Investigator: Sanjeev Kaul, MD
Phone: 248-336-1096
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Saint Petersburg, Florida 33710
Principal Investigator: Ketan Kapadia, MD
Phone: 727-381-8667
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San Jose, California 95124
Principal Investigator: Shahram Gholami, MD
Phone: 408-358-2030
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Savannah, Georgia 31406
Principal Investigator: Buffi Boyd, MD
Phone: 912-790-4837
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Shreveport, Louisiana 71106
Principal Investigator: Ralph J Henderson, MD
Phone: 318-683-0411
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Stony Brook, New York 11794
Principal Investigator: Howard Adler, MD
Phone: 631-638-0845
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Sunrise, Florida 33351
Principal Investigator: Jason Perelman, MD
Phone: 954-370-7555
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Syracuse, New York 13210
Principal Investigator: Neil Mariados, MD
Phone: 315-478-4185
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Troy, Michigan 48084
Principal Investigator: Kenneth Kernen, MD
Phone: 248-786-0467
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Tupelo, Mississippi 38801
Principal Investigator: CS Farmer, MD
Phone: 662-377-7896
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Virginia Beach, Virginia 23462
Phone: 757-452-3453
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West Columbia, South Carolina 29169
Principal Investigator: T. Brian Willard, MD
Phone: 704-414-2870
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Westchester, Illinois 60154
Principal Investigator: Paul Yonover, MD
Phone: 708-273-3735
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2626 North Webb Road
Wichita, Kansas 67226
Principal Investigator: Timothy Richardson, MD
Phone: 316-636-6141
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