Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery

Prostate Cancer Clinical Trial

— PRO-IMPACT  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080689
• Other study ID #: CU 004
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 24, 2017
• Start date: May 2014
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2017
• Source: GenomeDx Biosciences Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Decipher

Locations

Country	Name	City	State
United States	Alaska Urology Institute Alaska Clinical Research Center	Anchorage	Alaska
United States	University of Colorado, Denver Medical Campus	Aurora	Colorado
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	UT Southwestern Medical Center	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Carolina Urology Partners	Gastonia	North Carolina
United States	Spectrum Health Medical Group	Grand Rapids	Michigan
United States	Urological Research Network	Hialeah	Florida
United States	Lakeland Regional Health Systems	Lakeland	Florida
United States	Lancaster Urology	Lancaster	Pennsylvania
United States	Cedars-Sinai Medical Center	Los Angeles,	California
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Virginia Urology	Richmond	Virginia
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington
United States	Delaware Valley Urology, LLC	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
GenomeDx Biosciences Corp	Society of Urologic Oncology (SUO)

Country where clinical trial is conducted

United States, 

References & Publications (13)

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, 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. — View 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. — View 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. — View 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. — View 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. — View 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. — 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. — View Citation

Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19. — 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. — 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices		3 months
Secondary	Measure the number of participants for which treatment was Increased or decreased in the intensity.	This outcome will compare recommended treatment pre-Decipher to recommended treatment post-Decipher	3 months
Secondary	The number of different treatment plans most influenced by Decipher as a measure of clinical utility		12 months
Secondary	Comparison of type of treatment plans between high risk and low risk patients	How many treatment plans are similar for those considered at high versus low risk by Decipher test	6 months
Secondary	Account for the number of specific treatment assignments that correlated with a change in treatment recommendation		12 months
Secondary	Frequency of follow visits as a measure of reproducibility	The extent to which the Decipher test results influence urologist recommendations on frequency of follow-up for patients	12 months
Secondary	Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool		3 months
Secondary	Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance		12 months
Secondary	A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients	The extent to which the Decipher test results affect patient comfort level with treatment decisions as based on QOL and treatment regret tools	12 months
Secondary	Evaluate number of participants which show coherence to treatment decisions	For how many cases was the original selected treatment for a patient actually executed upon	12 months

External Links

•   The Society of Urologic Oncology (SUO)