Prostate CancerNCT03290508
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
An observational study of Prostate Cancer, run by Myriad Genetic Laboratories, Inc. at 34 sites in United States.
Trial summary
This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes… Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prolaris Testing
- How many people
- 524 participants
- Where
- 34 sitesUnited States
- Study dates
- 14 Sep 2017to 14 Jan 2022
- How long will I take part?
- 8 Years
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk localized prostate cancer whose initial treatment has not been decided and who are being seen at Medicare Certification and Training Registry (CTR) practices in the United States.
Who may be able to join
- Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
- Willing to provide written informed consent.
- Males ≥65 years old.
- Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
- Candidate for and considering AS and yet would be eligible for definitive therapy.
- Favorable intermediate-risk disease, defined by the NCCN as follows:
Show all 14Show fewer
- predominant Gleason grade 3; AND
- percentage of positive cores <50%; AND
- no more than 1 of the following NCCN intermediate-risk factors:
- Gleason grade 7
- T2b-T2c
- PSA 10-20 ng/mL
- Estimated life expectancy ≥10 years.
- Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
Who cannot join
- 1. Clinical evidence of metastasis or lymph node involvement.
- 2. Received pelvic radiation prior to biopsy.
- 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
- 4. Participation in interventional clinical trials.
- 5. Patient is considering watchful waiting.
- 6. Has a known history of hypogonadism.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Michigan, Department of Urologic Oncology
Ann Arbor, Michigan, 48109
Tufts Medical Center
Boston, Massachusetts, 02111
Seattle Urology Research Center
Burien, Washington, 98166
Medical University of South Carolina
Charleston, South Carolina, 29425
North Idaho Urology
Coeur d'Alene, Idaho, 83814
Pacific Urology
Concord, California, 94520
Premier Urology Group, LLC
Cranford, New Jersey, 07016
Premier Urology
Cranford, New Jersey, 07016
Advanced Urology Institute
Daytona Beach, Florida, 32114
Urology Group of Florida
Delray Beach, Florida, 33484
Rio Grande Urology
El Paso, Texas, 79912
Urologic Research and Consulting LLC
Englewood, New Jersey, 07631
Urology Centers of Alabama
Homewood, Alabama, 35209
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Arkansas Urology
Little Rock, Arkansas, 72211
VA Long Beach Healthcare
Long Beach, California, 90822
East Valley Urology Center
Mesa, Arizona, 85206
Urology Associates
Nashville, Tennessee, 37209
UCI Medical Center
Orange, California, 92866
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Comprehensive Urology
Royal Oak, Michigan, 48073
Ssg Md Apc
San Jose, California, 95124
Meridian Clinical Research
Savannah, Georgia, 31405
Regional Urology
Shreveport, Louisiana, 71106
Pinellas Urology
St. Petersburg, Florida, 33710
Stony Brook University
Stony Brook, New York, 11794
21st Century Oncology
Sunrise, Florida, 33351
A.M.P. Radiation Oncology
Syracuse, New York, 13210
Michigan Institute of Urology
Troy, Michigan, 48084
UroLogic
Tupelo, Mississippi, 38801
Carolina Urology Partners
West Columbia, South Carolina, 29163
URO Partners
Westchester, Illinois, 60154
Wichita Urology
Wichita, Kansas, 67226
About this study
Official title: Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)
This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.
Read the detailed description
This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.
Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
- Conditions
- Prostate Cancer
- Being tested
- Prolaris Testing
- Keywords
- Prolaris, Prostate Cancer, Cell Cycle Progression Test
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolaris TestingDiagnostic test
Also called RNA expression signature of cell cycle progression genes
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
| Study group | Role | What they receive |
|---|---|---|
| Prolaris Testing | Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing Receives: Diagnostic Test: Prolaris Testing | |
| No Prolaris Testing | Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Prolaris Score, on Active Surveillance
Proportion of patients with low Prolaris scores who are initially treated with active surveillance
Measured: 3 years
Low Prolaris Score, Definitive Treatment Following Active Surveillance
Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
Measured: 3 years
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.
Measured: 8 years
Secondary outcomes (5)
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.
Measured: 8 years
No Prolaris Score, on Active Surveillance
Proportion of patients without Prolaris testing who are initially treated with active surveillance.
Measured: 3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance
Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.
Measured: 3 years
No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.
Measured: 8 years
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start14 Sep 2017
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Why it stopped: There is sufficient follow-up data to meet the endpoints of the study.
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
- 524 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290508
- Sponsor's protocol ID
- URO-008
- Status last verified
- Jun 2022
- First submitted
- 19 Sep 2017
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)
- ClinicalTrials.gov ID
- NCT03290508
- Acronym / sponsor ID
- URO-008
- Conditions
- Prostate Cancer
- Keywords
- Prolaris, Prostate Cancer, Cell Cycle Progression Test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There is sufficient follow-up data to meet the endpoints of the study.
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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 long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.
Detailed description
This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.
Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolaris Testing | – | Diagnostic Test: Prolaris TestingRecently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing |
| No Prolaris Testing | – | –Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk localized prostate cancer whose initial treatment has not been decided and who are being seen at Medicare Certification and Training Registry (CTR) practices in the United States.
Key inclusion criteria (14 listed)
- Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
Key exclusion criteria (6 listed)
- 1. Clinical evidence of metastasis or lymph node involvement.
- 2. Received pelvic radiation prior to biopsy.
- 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
- 4. Participation in interventional clinical trials.
- 5. Patient is considering watchful waiting.
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 |
|---|---|---|
| Prolaris TestingAlso: RNA expression signature of cell cycle progression genesRecently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing | Diagnostic test | Prolaris Testing |
Primary outcome
Low Prolaris Score, on Active Surveillance
Time frame: 3 years
Proportion of patients with low Prolaris scores who are initially treated with active surveillance
Low Prolaris Score, Definitive Treatment Following Active Surveillance
Time frame: 3 years
Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Time frame: 8 years
Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.
5 secondary outcomes
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
Time frame: 8 years
No Prolaris Score, on Active Surveillance
Time frame: 3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance
Time frame: 3 years
No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
Time frame: 8 years
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Time frame: 8 years
Results and safety
The study was stopped early (reason given: There is sufficient follow-up data to meet the endpoints of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: Yes. Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites 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 34 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 14 inclusion and 6 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 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 was stopped early (reason given: There is sufficient follow-up data to meet the endpoints of the study.). 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?
Low Prolaris Score, on Active Surveillance (time frame: 3 years). The study lists 3 primary outcomes in all. 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 23 Jun 2022.