Prostate CancerDECIDENCT02020876
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations
An observational study of Prostate Cancer, run by GenomeDx Biosciences Corp at 1 site in United States.
Trial summary
This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DECIPHER Questionnaire
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.
Who may be able to join
- Practicing board-certified urologic surgeons
- Performing at least 40 radical prostate surgeries annually
- Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:
- Pathological Gleason score >= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery
Who cannot join
- Did not meet the inclusion criteria
- Criteria (Case selection)
- Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
GenomeDx Bioscience Inc.
San Diego, California, 92121
About this study
Official title: GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?
This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher
Read the detailed description
The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)
- Conditions
- Prostate Cancer
- Being tested
- DECIPHER Questionnaire
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECIPHER QuestionnaireOther
Participants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases.
| Study group | Role | What they receive |
|---|---|---|
| Practicing urologic surgeons | Performing at least 60 radical prostate surgeries annually Receives: Other: DECIPHER Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in treatment recommendation
To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP).
This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.
Measured: 1.5 years
Secondary outcomes (1)
Urologist's perception regarding the utility of the Decipher
- Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey.
- Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey.
- Agreement in treatment recommendation
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenomeDx Biosciences Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elai Davicioni, pHd, Principal investigator, GenomeDx Biosciences Inc.Badani Ketan, MD, Principal investigator, Department of Urology, Columbia University, New York, NY USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020876
- Sponsor's protocol ID
- CU001
- Acronym
- DECIDE
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23592338
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?
- ClinicalTrials.gov ID
- NCT02020876
- Acronym / sponsor ID
- DECIDE / CU001
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GenomeDx Biosciences CorpIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Dec 2013 (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.
This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher
Detailed description
The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Practicing urologic surgeons | – | Other: DECIPHER QuestionnairePerforming at least 60 radical prostate surgeries annually |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.
Key inclusion criteria (4 listed)
- Practicing board-certified urologic surgeons
- Performing at least 40 radical prostate surgeries annually
- Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:
- Pathological Gleason score >= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery
Key exclusion criteria (3 listed)
- Did not meet the inclusion criteria
- Criteria (Case selection)
- Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, 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 QuestionnaireParticipants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases. | Other | Practicing urologic surgeons |
Primary outcome
Change in treatment recommendation
Time frame: 1.5 years
To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.
1 secondary outcome
Urologist's perception regarding the utility of the Decipher
Time frame: 1.5 years
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 25 Dec 2013.
- Results publication: PubMed 23592338Badani 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.
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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.
Elai Davicioni, pHd principal investigator
GenomeDx Biosciences Inc.
Badani Ketan, MD principal investigator
Department of Urology, Columbia University, New York, NY USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by GenomeDx Biosciences Corp at 1 site 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 4 inclusion and 3 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in treatment recommendation (time frame: 1.5 years). 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 NCT02020876, which also lists 1 linked publication.
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 25 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.