Clinical trial NCT02034825: Multi-site Decision Impact Study for Decipher
Official title: ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: GenomeDx Biosciences Corp
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
First posted: 2014-01-14
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Detailed description: The clinical utility of Decipher will be evaluated at two time-points:

1. Post RP - within 6 months after surgery
2. PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations

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):

1. Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case.
2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.

Eligibility criteria: 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:

* 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

Exclusion Criteria:

1. Metastatic Disease (M+) prior to surgery
2. Failure of PSA to nadir after surgery
3. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
4. Received any adjuvant chemotherapy
5. Required patient clinical data (Section 5.3) is not available for evaluation of eligibility criteria
6. Lack of documented treatment or management recommendation on file
7. Tissue specimen is inadequate for sampling and analysis

Primary outcomes:
measure: Change in treatment recommendation
timeFrame: 1.5 years
Secondary outcomes:
measure: Specific change in treatment recommendation
timeFrame: 1.5 years
measure: Changes in intensity of treatment
timeFrame: 1.5 years
measure: Change in treatment recommendation compared to baseline
timeFrame: 1.5 years
measure: Confidence in treatment recommendation
timeFrame: 1.5 years
measure: Changes in the decision conflict scale
timeFrame: 1.5 years
measure: Utility of Decipher
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Cedar Associates LLC
state: California
city: Celebration
country: United States
facility: Florida Hospital
state: Florida
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Badani K Ketan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GenomeDx Biosciences Inc.
name: Christine d Buerki, PhD
role: STUDY_DIRECTOR
affiliation: AdventHealth
name: Vipul Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.