Prostate CancerNCT02454595
Registry to Measure the Impact of Adding Genomic Testing
An observational study of Prostate Cancer, run by Myriad Genetic Laboratories, Inc. at 1 site in United States.
Trial summary
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Registry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 3 Jul 2017
- How long will I take part?
- 3 Months
- 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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
Who may be able to join
- Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
- PSA less than or equal to 10 ng/dl and
- Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
- Age greater than 55 years old and
- Clinical Stage T1 or T2
- Clinically localized (no evidence on clinical or imaging studies of advanced disease).
- No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
Who cannot join
- Known history of hypogonadism
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare
Salt Lake City, Utah, 84107
About this study
Official title: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.
Read the detailed description
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).
- Conditions
- Prostate Cancer
- Being tested
- Registry
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryBehavioural
Also called Prolaris
Physician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test).
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startNov 2014
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Wenstrup, MD, Study director, Myriad Genetic Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454595
- Sponsor's protocol ID
- URO-006
- Status last verified
- Jul 2017
- First submitted
- 4 May 2015
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals
- ClinicalTrials.gov ID
- NCT02454595
- Acronym / sponsor ID
- URO-006
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- Nov 2014
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 27 May 2015 (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 is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.
Detailed description
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
Key inclusion criteria (7 listed)
- Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
- PSA less than or equal to 10 ng/dl and
- Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
- Age greater than 55 years old and
- Clinical Stage T1 or T2
Key exclusion criteria (1 listed)
- Known history of hypogonadism
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 |
|---|---|---|
| RegistryAlso: ProlarisPhysician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test). | Behavioural | – |
Primary outcome
The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.
Time frame: Three months
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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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.
Richard Wenstrup, MD study director
Myriad Genetic Laboratories, Inc.
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 Myriad Genetic Laboratories, Inc. 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 7 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Sep 2017. 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 was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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?
The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.