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

Use our guide to learn which trials are right for you!

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