Multi-site Decision Impact Study for Decipher

Prostate Cancer Clinical Trial

— ASSESS-D  

Official title:

ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034825
• Other study ID #: CU003
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: February 26, 2016
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: GenomeDx Biosciences Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Florida Hospital	Celebration	Florida
United States	Cedar Associates LLC	Menlo Park	California
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
GenomeDx Biosciences Corp	Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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, Maréchal JM, Scalliet P, Haustermans K, Piérart 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Störkel S, Willich N, Semjonow A, Souchon R, Stöckle M, Rübe C, Weissbach L, Althaus P, Rebmann U, Kälble 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Changes in intensity of treatment	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	No
Secondary	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	No
Secondary	Confidence in treatment recommendation	Changes in urologists expressed level of confidence in the treatment recommendation	1.5 years	No
Secondary	Changes in the decision conflict scale		1.5 years	No
Secondary	Utility of Decipher	Urologist's perception regarding the utility of the Decipher test	1.5 years	No