Multi-site Decision Impact Study for Decipher

NCT02034825 | Completed

• 1 other identifier: CU003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in treatment recommendation

  Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. Specifically this will be defined as (pre- to post-): RT to ADT RT to ADT \& RT RT to Observation ADT to RT ADT to ADT \& RT ADT to Observation ADT \& RT to RT ADT \& RT to ADT ADT \& RT to Observation Observation to RT Observation to ADT Observation to RT \& ADT

  1.5 years

Secondary Outcomes (6)

• Specific change in treatment recommendation

  1.5 years

• Changes in intensity of treatment

  1.5 years

• Change in treatment recommendation compared to baseline

  1.5 years

• Confidence in treatment recommendation

  1.5 years

• Changes in the decision conflict scale

  1.5 years

Study Arms (1)

Practicing urologic surgeons

* US board-certified * Practicing urologic surgeons * Performing at least 40 radical prostate surgeries annually Urologists will be excluded from participating in the study if: * They are unable to identify a the required number of eligible patient cases with available clinical data and tissue specimens; * They have spent less than 3 years in practice or perform less than 40 RP's per year All participants will be asked to complete a questionnaire based on a random selection of retroactively selected cases.

Other: Decipher Questionnaire

Interventions

Decipher Questionnaire OTHER

Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.

Practicing urologic surgeons

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively

You may qualify if:

• Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:
• Pathological T3 stage of disease (i.e., ECE or SVI)
• Positive surgical margins, or
• Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

You may not qualify if:

• Metastatic Disease (M+) prior to surgery
• 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 (Section 5.3) is not available for evaluation of eligibility criteria
• Lack of documented treatment or management recommendation on file
• Tissue specimen is inadequate for sampling and analysis

Sponsors & Collaborators

• GenomeDx Biosciences Corp: lead
• Columbia University: collaborator

Study Sites (3)

Cedar Associates LLC

Menlo Park, California, 94025, United States

Location

Florida Hospital

Celebration, Florida, 34747, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (7)

• 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, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.

  PMID: 16099293 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

• 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

• Schreiber D, Rineer J, Sura S, Teper E, Nabhani T, Han P, Schwartz D, Choi K, Rotman M. Radical prostatectomy for cT3-4 disease: an evaluation of the pathological outcomes and patterns of care for adjuvant radiation in a national cohort. BJU Int. 2011 Aug;108(3):360-5. doi: 10.1111/j.1464-410X.2010.09875.x. Epub 2010 Nov 18.

  PMID: 21087395 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

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

• Badani K Ketan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Christine d Buerki, PhD

  GenomeDx Biosciences Inc.

  STUDY DIRECTOR

• Vipul Patel, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 29, 2016

Record last verified: 2015-03

Locations

US (3)