Prostate CancerPRO-IMPACTNCT02080689
Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
A study testing Decipher in people with Prostate Cancer, run by GenomeDx Biosciences Corp at 19 sites in United States.
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 Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Decipher
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2014to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathological T3 stage of disease (i.e., EPE or SVI), or
- Positive surgical margins, or
- Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
Who cannot join
- For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
- For salvage setting patients: Metastatic Disease at PSA rise
- Failure of PSA to nadir after surgery
- Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
- Received any adjuvant chemotherapy
- Required patient clinical data is not available for evaluation of eligibility criteria
Show all 9Show fewer
- For adjuvant setting patients, any treatment received after surgery
- For salvage setting patients, lack of documented treatment or management recommendation on file
- Tissue specimen is inadequate for sampling and analysis
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Alaska Urology Institute Alaska Clinical Research Center
Anchorage, Alaska, 99503
University of Colorado, Denver Medical Campus
Aurora, Colorado, 80045
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Vermont Medical Center
Burlington, Vermont, 05401
UT Southwestern Medical Center
Dallas, Texas, 753910-9110
The Urology Center of Colorado
Denver, Colorado, 80211
Carolina Urology Partners
Gastonia, North Carolina, 28054
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546
Urological Research Network
Hialeah, Florida, 33016
Lakeland Regional Health Systems
Lakeland, Florida, 33805
Lancaster Urology
Lancaster, Pennsylvania, 17604
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami Miller School of Medicine
Miami, Florida, 33101
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Virginia Urology
Richmond, Virginia, 23235
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
University of Washington
Seattle, Washington
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, 08043
About this study
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]
The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR
Read the 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:
- In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
- 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.
- Conditions
- Prostate Cancer
- Being tested
- Decipher
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecipherOther
| Study group | Role | What they receive |
|---|---|---|
| Salvage setting | Other | 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) Receives: Other: Decipher |
| Adjuvant setting | Other | 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) Receives: Other: Decipher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Measured: 3 months
Secondary outcomes (9)
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
Measured: 3 months
The number of different treatment plans most influenced by Decipher as a measure of clinical utility
Measured: 12 months
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
Measured: 6 months
Account for the number of specific treatment assignments that correlated with a change in treatment recommendation
Measured: 12 months
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
Measured: 12 months
Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool
Measured: 3 months
Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenomeDx Biosciences Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Society of Urologic Oncology (SUO)
- Responsible party
- Sponsor
- Investigators
- Daniel W Lin, MD, Principal investigator, The Society of Urologic Oncology (SUO)John L Gore, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080689
- Sponsor's protocol ID
- CU 004
- Acronym
- PRO-IMPACT
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2014
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21402604Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19.
PubMed 21197260Silberstein 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.
PubMed 21484780Thompson 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.
PubMed 19167731Bolla 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.
PubMed 23084481Wiegel 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.
PubMed 19433689Zelefsky 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.
PubMed 20159826Thompson 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.
PubMed 17105795Hoffman 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.
PubMed 21074194Moinpour 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.
PubMed 18165645Erho 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.
PubMed 23826159Karnes 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.
PubMed 23770138Badani 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.
PubMed 23592338
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02080689
- Acronym / sponsor ID
- PRO-IMPACT / CU 004
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- GenomeDx Biosciences CorpIndustry (pharma, biotech, devices)
- Collaborators
- Society of Urologic Oncology (SUO)
- Study start
- May 2014
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvage setting | Other | Other: DecipherThe 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) |
| Adjuvant setting | Other | Other: DecipherThe 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) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pathological T3 stage of disease (i.e., EPE or SVI), or
- Positive surgical margins, or
- Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
Key exclusion criteria (9 listed)
- For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
- For salvage setting patients: Metastatic Disease at PSA rise
- Failure of PSA to nadir after surgery
- Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
- Received any adjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decipher | Other | Adjuvant setting, Salvage setting |
Primary outcome
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Time frame: 3 months
9 secondary outcomes
Measure the number of participants for which treatment was Increased or decreased in the intensity.
Time frame: 3 months
The number of different treatment plans most influenced by Decipher as a measure of clinical utility
Time frame: 12 months
Comparison of type of treatment plans between high risk and low risk patients
Time frame: 6 months
Account for the number of specific treatment assignments that correlated with a change in treatment recommendation
Time frame: 12 months
Frequency of follow visits as a measure of reproducibility
Time frame: 12 months
Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool
Time frame: 3 months
Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance
Time frame: 12 months
A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients
Time frame: 12 months
Evaluate number of participants which show coherence to treatment decisions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 21402604Nguyen 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.
- Background: PubMed 21197260Swanson GP, Basler JW. Prognostic factors for failure after prostatectomy. J Cancer. 2010 Dec 7;2:1-19.
- Background: PubMed 21484780Silberstein 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.
- Background: PubMed 19167731Thompson 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.
- Background: PubMed 23084481Bolla 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.
- Background: PubMed 19433689Wiegel 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.
- Background: PubMed 20159826Zelefsky 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.
- Background: PubMed 17105795Thompson 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.
- Background: PubMed 21074194Hoffman 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.
- Background: PubMed 18165645Moinpour 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.
- Background: PubMed 23826159Erho 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.
- Background: PubMed 23770138Karnes 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.
- The Society of Urologic Oncology (SUO)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Lin, MD principal investigator
The Society of Urologic Oncology (SUO)
John L Gore, MD principal investigator
University of Washington
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decipher in people with Prostate Cancer, run by GenomeDx Biosciences Corp at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080689, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.