Prostate CancerNCT04897958
Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
An observational study of Prostate Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix and Leuprolide
- How many people
- 14,417 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2019to 1 Aug 2021
- 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
- Child, Adult, Older adult
Study population: Subjects were selected on the basis of having at least one diagnosis code indicating prostate cancer, male sex, and a history of artherosclerotic cardiovascular disease. In contrast to the the PRONOUNCE RCT trial, patients cannot be required to have had established tumor staging information, angiography-verified stenosis/occlusion of vessels, and a lack of planned cardiac surgery at the time of treatment initiation due to poor capture of this information administrative data. All patients were required to have continuous enrollment for 365 days prior to cohort entry to ensure incident use of the study drugs.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Pre-existing ASCVD (confirmed diagnosis, documented) according to a least 1 of the following criteria:
- Previous MI >= 30 days before randomization
- Previous revascularization procedure >= 30 days before randomization
- Coronary artery: stent placement/balloon angioplasty or coronary artery bypass graft surgery
- Carotid artery: stent placement/balloon angioplasty or endarterectomy surgery
- Iliac, femoral, popliteal arteries: stent placement/balloon angioplasty or vascular bypass surgery
Who cannot join
- Treatment naivety (ADT)
- Previous or current hormonal management of prostate cancer including surgical castration, any hormonal manipulation, or any previous neoadjuvant/adjuvant hormonal therapy, unless treatment was terminated more than 12 months prior to enrollment
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Uncontrolled hypertension
- A history of congenital long QT syndrome or risk factors for Torsade de pointes ventricular arrhythmias
- MI; stroke; or coronary, carotid, or peripheral artery revascularization
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Leuprolide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Degarelix dispensing claim is used as the reference group.
LeuprolideDrug
Leuprolide dispensing claim is used as the exposure group.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Reference group Receives: Drug: Degarelix | |
| Leuprolide | Exposure group Receives: Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause mortality, nonfatal MI, and nonfatal stroke
Measured: Through study completion (earliest of 336 days or censoring)
Secondary outcomes (3)
All-Cause Mortality
Component of MACE
Measured: Through study completion (earliest of 336 days or censoring)
Nonfatal MI
Component of MACE
Measured: Through study completion (earliest of 336 days or censoring)
Nonfatal Stroke
Component of MACE
Measured: Through study completion (earliest of 336 days or censoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Sep 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
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.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 14,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897958
- Sponsor's protocol ID
- 2018P002966-DUP-PRONOUNCE
- Status last verified
- Jul 2023
- First submitted
- 17 May 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04897958
- Acronym / sponsor ID
- 2018P002966-DUP-PRONOUNCE
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,417 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 24 May 2021 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix | – | Drug: DegarelixReference group |
| Leuprolide | – | Drug: LeuprolideExposure group |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects were selected on the basis of having at least one diagnosis code indicating prostate cancer, male sex, and a history of artherosclerotic cardiovascular disease. In contrast to the the PRONOUNCE RCT trial, patients cannot be required to have had established tumor staging information, angiography-verified stenosis/occlusion of vessels, and a lack of planned cardiac surgery at the time of treatment initiation due to poor capture of this information administrative data. All patients were required to have continuous enrollment for 365 days prior to cohort entry to ensure incident use of the study drugs.
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Pre-existing ASCVD (confirmed diagnosis, documented) according to a least 1 of the following criteria:
- Previous MI >= 30 days before randomization
- Previous revascularization procedure >= 30 days before randomization
- Coronary artery: stent placement/balloon angioplasty or coronary artery bypass graft surgery
Key exclusion criteria (6 listed)
- Treatment naivety (ADT)
- Previous or current hormonal management of prostate cancer including surgical castration, any hormonal manipulation, or any previous neoadjuvant/adjuvant hormonal therapy, unless treatment was terminated more than 12 months prior to enrollment
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Uncontrolled hypertension
- A history of congenital long QT syndrome or risk factors for Torsade de pointes ventricular arrhythmias
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 |
|---|---|---|
| DegarelixDegarelix dispensing claim is used as the reference group. | Drug | Degarelix |
| LeuprolideLeuprolide dispensing claim is used as the exposure group. | Drug | Leuprolide |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: Through study completion (earliest of 336 days or censoring)
Composite of all-cause mortality, nonfatal MI, and nonfatal stroke
3 secondary outcomes
All-Cause Mortality
Time frame: Through study completion (earliest of 336 days or censoring)
Nonfatal MI
Time frame: Through study completion (earliest of 336 days or censoring)
Nonfatal Stroke
Time frame: Through study completion (earliest of 336 days or censoring)
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 Jul 2023.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
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 Brigham and Women's Hospital 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 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: finished, as of the sponsor's last update on 27 Jul 2023. 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?
Major Adverse Cardiovascular Events (MACE) (time frame: Through study completion (earliest of 336 days or censoring)). 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 27 Jul 2023.