Clinical trial · Observational
Multi-site Decision Impact Study for Decipher
ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
NCT02034825CI-TRIAL-00021177ASSESS-DcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decipher Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Practicing urologic surgeons
- description
- * 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.
- interventionNames
- Other: Decipher Questionnaire
Primary outcomes (1)
- measure
- Change in treatment recommendation
- timeFrame
- 1.5 years
- description
- 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
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSilberstein 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
- BACKGROUNDThompson 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
- BACKGROUNDBolla 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
- BACKGROUNDWiegel 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
- BACKGROUNDThompson 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