Prostate CancerP-PROVENCT03152448
Prospective Prolaris Value and Efficacy
An observational study of Prostate Cancer, run by Myriad Genetic Laboratories, Inc. at 12 sites in United States.
Trial summary
This is a prospective study 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prolaris
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,511 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Sep 2015to 21 Mar 2022
- How long will I take part?
- 5 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
Who may be able to join
- Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
- Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
- Clinically localized (no evidence on clinical or imaging studies of advanced disease)
- No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
- Sufficient amount of tissue remains from biopsy to perform genomic testing
- Life expectance of a minimum of 10 years
- Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.
Who cannot join
- Men with clinical node positive or metastatic disease
- Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
- Men who previously received pelvic radiotherapy for another malignancy
- Non adenocarcinoma prostate cancer histologies
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
Michael E. DeBakey VAMC
Houston, Texas, 77030
Kansas City VAMC
Kansas City, Kansas, 64128
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417
Southeast Louisiana Veterans Healtchare System
New Orleans, Louisiana, 70112
Oklahoma City Veteran's Hospital
Oklahoma City, Oklahoma, 73104
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
VA San Diego Healthcare System
San Diego, California, 92161
VA St. Louis Healthcare System
St Louis, Missouri, 63106
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
James J. Peters VA
The Bronx, New York, 10468
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC
This is a prospective study 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.
Read the detailed description
This is a prospective study 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. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. 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 and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.
PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.
- Conditions
- Prostate Cancer
- Being tested
- Prolaris
- Keywords
- Prolaris, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlarisBehavioural
Also called RNA expression signature based on a set of cell cycle progression (CCP) genes
Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result
| Study group | Role | What they receive |
|---|---|---|
| Early Stage Prostate Cancer | Recently diagnosed treatment-naïve patients with early stage localized prostate cancer Receives: Behavioral: Prolaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment
Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris
Measured: 6 months
Prolaris prediction of biochemical or objective recurrence
Biochemical recurrence (defined as PSA >0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Sep 2015
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Why it stopped: Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.
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
- 1,511 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Salt Lake City Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152448
- Sponsor's protocol ID
- URO-005
- Acronym
- P-PROVE
- Status last verified
- Jun 2022
- First submitted
- 19 Feb 2016
- Last updated
- 13 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 provider and patient per commercial process; study results to be presented in a pier reviewed publication in aggregate form only (no individual participant data to be shared through publications or abstracts)
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC
- ClinicalTrials.gov ID
- NCT03152448
- Acronym / sponsor ID
- P-PROVE / URO-005
- Conditions
- Prostate Cancer
- Keywords
- Prolaris, Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.
- Enrolment
- 1,511 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VA Salt Lake City Health Care System
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 15 May 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 prospective study 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.
Detailed description
This is a prospective study 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. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. 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 and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.
PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Stage Prostate Cancer | – | Behavioral: ProlarisRecently diagnosed treatment-naïve patients with early stage localized prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
Key inclusion criteria (7 listed)
- Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
- Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
- Clinically localized (no evidence on clinical or imaging studies of advanced disease)
- No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
- Sufficient amount of tissue remains from biopsy to perform genomic testing
Key exclusion criteria (4 listed)
- Men with clinical node positive or metastatic disease
- Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
- Men who previously received pelvic radiotherapy for another malignancy
- Non adenocarcinoma prostate cancer histologies
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 |
|---|---|---|
| ProlarisAlso: RNA expression signature based on a set of cell cycle progression (CCP) genesSeries of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result | Behavioural | Early Stage Prostate Cancer |
Primary outcome
Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment
Time frame: 6 months
Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris
Prolaris prediction of biochemical or objective recurrence
Time frame: 5 years
Biochemical recurrence (defined as PSA >0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy
Results and safety
The study was stopped early (reason given: Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. Results of Prolaris testing to be shared with provider and patient per commercial process; study results to be presented in a pier reviewed publication in aggregate form only (no individual participant data to be shared through publications or abstracts)
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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.
12 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 12 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 7 inclusion and 4 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 13 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 12 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: Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.). 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?
Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment (time frame: 6 months). The study lists 2 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 13 Jun 2022.