Clinical trial NCT02080689: Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
Official title: PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: GenomeDx Biosciences Corp
Sponsor class: INDUSTRY
Collaborators: name: Society of Urologic Oncology (SUO)
First posted: 2014-03-06
Enrollment: 286
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Detailed description: This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP:

1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
2. 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)

A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases.

As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
timeFrame: 3 months
Secondary outcomes:
measure: Measure the number of participants for which treatment was Increased or decreased in the intensity.
timeFrame: 3 months
measure: The number of different treatment plans most influenced by Decipher as a measure of clinical utility
timeFrame: 12 months
measure: Comparison of type of treatment plans between high risk and low risk patients
timeFrame: 6 months
measure: Account for the number of specific treatment assignments that correlated with a change in treatment recommendation
timeFrame: 12 months
measure: Frequency of follow visits as a measure of reproducibility
timeFrame: 12 months
measure: Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool
timeFrame: 3 months
measure: Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance
timeFrame: 12 months
measure: A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients
timeFrame: 12 months
measure: Evaluate number of participants which show coherence to treatment decisions
timeFrame: 12 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urology Institute Alaska Clinical Research Center
state: Alaska
city: Los Angeles,
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver Medical Campus
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Hialeah
country: United States
facility: Urological Research Network
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health Systems
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Voorhees
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: The Society of Urologic Oncology (SUO)
name: Daniel W Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: John L Gore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen 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.
citation: Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19.
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, 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.
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: Zelefsky MJ, Eastham JA, Cronin AM, Fuks Z, Zhang Z, Yamada Y, Vickers A, Scardino PT. Metastasis after radical prostatectomy or external beam radiotherapy for patients with clinically localized prostate cancer: a comparison of clinical cohorts adjusted for case mix. J Clin Oncol. 2010 Mar 20;28(9):1508-13. doi: 10.1200/JCO.2009.22.2265. Epub 2010 Feb 16.
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: Hoffman KE, Nguyen PL, Chen MH, Chen RC, Choueiri TK, Hu JC, Kuban DA, D'Amico AV. Recommendations for post-prostatectomy radiation therapy in the United States before and after the presentation of randomized trials. J Urol. 2011 Jan;185(1):116-20. doi: 10.1016/j.juro.2010.08.086. Epub 2010 Nov 12.
citation: Moinpour CM, Hayden KA, Unger JM, Thompson IM Jr, Redman MW, Canby-Hagino ED, Higgins BA, Sullivan JW, Lemmon D, Breslin S, Crawford ED, Southwest Oncology Group. Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy. J Clin Oncol. 2008 Jan 1;26(1):112-20. doi: 10.1200/JCO.2006.10.4505.
citation: Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013.
citation: Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.
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.