Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:6/22/2016
Start Date:May 2014
End Date:March 2017

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PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]

The influence of Decipher test on urologist and patient treatment plan choices immediately
post RP and at the time of PSA rise or BCR

This prospectively decision impact study will evaluate physicians and patient treatment plan
choices before and after reviewing Decipher results for eligible patient cases. The clinical
utility of Decipher will be evaluated for patients meeting the inclusion criteria at two
time-points post-RP:

1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable
PSA rise of BCR)

2. In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA
detectable and rising on 2 or more subsequent determinations)

A total of 150 patient cases, in each arm, will be prospectively selected from clinical
sites. The study as a whole will enroll 300 patient cases.

As a condition of participation in the study, each clinical site must agree to provide a
minimum of 10 patient cases.

Inclusion Criteria:

1. Pathological T3 stage of disease (i.e., EPE or SVI), or

2. Positive surgical margins, or

3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent
determinations

Exclusion Criteria:

1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery

2. For salvage setting patients: Metastatic Disease at PSA rise

3. Failure of PSA to nadir after surgery

4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy

5. Received any adjuvant chemotherapy

6. Required patient clinical data is not available for evaluation of eligibility
criteria

7. For adjuvant setting patients, any treatment received after surgery

8. For salvage setting patients, lack of documented treatment or management
recommendation on file

9. Tissue specimen is inadequate for sampling and analysis
We found this trial at
19
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Anchorage, AK
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Burlington, Vermont 05405
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Denver, Colorado 80211
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Gastonia, North Carolina 28054
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Grand Rapids, Michigan 69546
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Hialeah, Florida 33016
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Lakeland, Florida 33805
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Lancaster, Pennsylvania 17604
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, Pennsylvania 19111
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Richmond, Virginia 23235
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Salt Lake City, Utah 84112
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Voorhees, New Jersey 08043
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