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

NCT02080689 | Completed

• 1 other identifier: CU 004
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices

  3 months

Secondary Outcomes (9)

• Measure the number of participants for which treatment was Increased or decreased in the intensity.

  3 months

• The number of different treatment plans most influenced by Decipher as a measure of clinical utility

  12 months

• Comparison of type of treatment plans between high risk and low risk patients

  6 months

• Account for the number of specific treatment assignments that correlated with a change in treatment recommendation

  12 months

• Frequency of follow visits as a measure of reproducibility

  12 months

Study Arms (2)

Salvage setting

OTHER

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)

Other: Decipher

Adjuvant setting

OTHER

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)

Other: Decipher

Interventions

Decipher OTHER

Adjuvant setting; Salvage setting

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological T3 stage of disease (i.e., EPE or SVI), or
• Positive surgical margins, or
• Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

You may not qualify if:

• For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
• For salvage setting patients: Metastatic Disease at PSA rise
• Failure of PSA to nadir after surgery
• Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
• Received any adjuvant chemotherapy
• Required patient clinical data is not available for evaluation of eligibility criteria
• For adjuvant setting patients, any treatment received after surgery
• For salvage setting patients, lack of documented treatment or management recommendation on file
• Tissue specimen is inadequate for sampling and analysis

Sponsors & Collaborators

• GenomeDx Biosciences Corp: lead
• Society of Urologic Oncology (SUO): collaborator

Study Sites (19)

Alaska Urology Institute Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Colorado, Denver Medical Campus

Aurora, Colorado, 80045, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Urological Research Network

Hialeah, Florida, 33016, United States

Location

Lakeland Regional Health Systems

Lakeland, Florida, 33805, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33101, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spectrum Health Medical Group

Grand Rapids, Michigan, 49546, United States

Location

Delaware Valley Urology, LLC

Voorhees Township, New Jersey, 08043, United States

Location

Carolina Urology Partners

Gastonia, North Carolina, 28054, United States

Location

Lancaster Urology

Lancaster, Pennsylvania, 17604, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 753910-9110, United States

Location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

University of Washington

Seattle, Washington, United States

Location

Related Publications (13)

• 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.

  PMID: 21402604 BACKGROUND

• Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19.

  PMID: 21197260 BACKGROUND

• 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.

  PMID: 21484780 BACKGROUND

• 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.

  PMID: 19167731 BACKGROUND

• 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.

  PMID: 23084481 BACKGROUND

• 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.

  PMID: 19433689 BACKGROUND

• 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.

  PMID: 20159826 BACKGROUND

• 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.

  PMID: 17105795 BACKGROUND

• 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.

  PMID: 21074194 BACKGROUND

• 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.

  PMID: 18165645 BACKGROUND

• 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.

  PMID: 23826159 BACKGROUND

• 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.

  PMID: 23770138 BACKGROUND

• 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.

  PMID: 23592338 BACKGROUND

Related Links

• The Society of Urologic Oncology (SUO)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniel W Lin, MD

  The Society of Urologic Oncology (SUO)

  PRINCIPAL INVESTIGATOR

• John L Gore, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 6, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

US (19)