Clinical trial · Interventional
Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]
NCT02080689CI-TRIAL-00026168PRO-IMPACTcompletedN/AClinicalTrials.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)
The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR
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 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Salvage setting
- description
- The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria in the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)
- interventionNames
- Other: Decipher
- type
- OTHER
- label
- Adjuvant setting
- description
- The clinical utility of Decipher will be evaluated for patients in the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
- interventionNames
- Other: Decipher
Primary outcomes (1)
- measure
- Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Pathological T3 stage of disease (i.e., EPE or SVI), or 2. Positive surgical margins, or 3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations Exclusion Criteria: 1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery 2. For salvage setting patients: Metastatic Disease at PSA rise 3. Failure of PSA to nadir after surgery 4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy 5. Received any adjuvant chemotherapy 6. Required patient clinical data is not available for evaluation of eligibility criteria 7. For adjuvant setting patients, any treatment received after surgery 8. For salvage setting patients, lack of documented treatment or management recommendation on file 9. Tissue specimen is inadequate for sampling and analysis
References
Publications (13)
- BACKGROUNDNguyen PL, Gu X, Lipsitz SR, Choueiri TK, Choi WW, Lei Y, Hoffman KE, Hu JC. Cost implications of the rapid adoption of newer technologies for treating prostate cancer. J Clin Oncol. 2011 Apr 20;29(12):1517-24. doi: 10.1200/JCO.2010.31.1217. Epub 2011 Mar 14. PMID 21402604
- BACKGROUNDSwanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19. PMID 21197260
- 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, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet. 2012 Dec 8;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. Epub 2012 Oct 19. PMID 23084481
- 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.