Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
NCT ID: NCT02080689
Last Updated: 2017-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
286 participants
INTERVENTIONAL
2014-05-31
2017-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists
NCT02034812
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations
NCT02020876
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT05050084
Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance
NCT03502213
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
NCT00138918
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Salvage setting
The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria 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)
Decipher
Adjuvant setting
The clinical utility of Decipher will be evaluated for patients in the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
Decipher
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Decipher
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Positive surgical margins, or
3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
Exclusion Criteria
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
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Society of Urologic Oncology (SUO)
UNKNOWN
GenomeDx Biosciences Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel W Lin, MD
Role: PRINCIPAL_INVESTIGATOR
The Society of Urologic Oncology (SUO)
John L Gore, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alaska Urology Institute Alaska Clinical Research Center
Anchorage, Alaska, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado, Denver Medical Campus
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Lakeland Regional Health Systems
Lakeland, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Urology
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nguyen PL, Gu X, Lipsitz SR, Choueiri TK, Choi WW, Lei Y, Hoffman KE, Hu JC. Cost implications of the rapid adoption of newer technologies for treating prostate cancer. J Clin Oncol. 2011 Apr 20;29(12):1517-24. doi: 10.1200/JCO.2010.31.1217. Epub 2011 Mar 14.
Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19.
Silberstein JL, Vickers AJ, Power NE, Fine SW, Scardino PT, Eastham JA, Laudone VP. Reverse stage shift at a tertiary care center: escalating risk in men undergoing radical prostatectomy. Cancer. 2011 Nov 1;117(21):4855-60. doi: 10.1002/cncr.26132. Epub 2011 Apr 11.
Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.
Bolla M, van Poppel H, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet. 2012 Dec 8;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. Epub 2012 Oct 19.
Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, Willich N, Semjonow A, Souchon R, Stockle M, Rube C, Weissbach L, Althaus P, Rebmann U, Kalble T, Feldmann HJ, Wirth M, Hinke A, Hinkelbein W, Miller K. Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol. 2009 Jun 20;27(18):2924-30. doi: 10.1200/JCO.2008.18.9563. Epub 2009 May 11.
Zelefsky MJ, Eastham JA, Cronin AM, Fuks Z, Zhang Z, Yamada Y, Vickers A, Scardino PT. Metastasis after radical prostatectomy or external beam radiotherapy for patients with clinically localized prostate cancer: a comparison of clinical cohorts adjusted for case mix. J Clin Oncol. 2010 Mar 20;28(9):1508-13. doi: 10.1200/JCO.2009.22.2265. Epub 2010 Feb 16.
Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.
Hoffman KE, Nguyen PL, Chen MH, Chen RC, Choueiri TK, Hu JC, Kuban DA, D'Amico AV. Recommendations for post-prostatectomy radiation therapy in the United States before and after the presentation of randomized trials. J Urol. 2011 Jan;185(1):116-20. doi: 10.1016/j.juro.2010.08.086. Epub 2010 Nov 12.
Moinpour CM, Hayden KA, Unger JM, Thompson IM Jr, Redman MW, Canby-Hagino ED, Higgins BA, Sullivan JW, Lemmon D, Breslin S, Crawford ED, Southwest Oncology Group. Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy. J Clin Oncol. 2008 Jan 1;26(1):112-20. doi: 10.1200/JCO.2006.10.4505.
Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013.
Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.
Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918.
Related Links
Access external resources that provide additional context or updates about the study.
The Society of Urologic Oncology (SUO)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CU 004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.