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| Name | Class |
|---|---|
| Columbia University | OTHER |
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This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.
The clinical utility of Decipher will be evaluated at two time-points:
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. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.
The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.
Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practicing urologic surgeons |
Urologists will be excluded from participating in the study if:
All participants will be asked to complete a questionnaire based on a random selection of retroactively selected cases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Specific change in treatment recommendation | 1. Change in treatment recommendation from pre- to post-Decipher report defined as any of the following: Observation to Any treatment Any treatment to Observation | 1.5 years |
| Changes in intensity of treatment |
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Inclusion Criteria:
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:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Badani K Ketan, MD | Columbia University | Principal Investigator |
| Christine d Buerki, PhD | GenomeDx Biosciences Inc. | Study Director |
| Vipul Patel, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedar Associates LLC | Menlo Park | California | 94025 | United States | ||
| Florida Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21484780 | 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. | |
| 19167731 | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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2. Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity defined as: • Increasing intensity: RT to ADT RT to ADT & RT ADT to ADT & RT Observation to any treatment • Decreasing intensity: Any treatment to observation ADT & RT to ADT ADT & RT to RT ADT to RT |
| 1.5 years |
| Change in treatment recommendation compared to baseline | Changes in treatment recommendation (as described in the Primary Endpoint, and in Secondary Endpoints 1 and 2) from original, actual, treatment recommendation and post-Decipher recommendation. | 1.5 years |
| Confidence in treatment recommendation | Changes in urologists expressed level of confidence in the treatment recommendation | 1.5 years |
| Changes in the decision conflict scale | 1.5 years |
| Utility of Decipher | Urologist's perception regarding the utility of the Decipher test | 1.5 years |
| Celebration |
| Florida |
| 34747 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| 16099293 | 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. |
| 19433689 | 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. |
| 17105795 | 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. |
| 21087395 | 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. |
| 23592338 | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |