HRRm mCRPCADAMNCT04712890
Determination of Prevalence and Features of HRRm mCRPC (ADAM)
An observational study of HRRm mCRPC, run by AstraZeneca at 14 sites in Russia.
Trial summary
Study design: This study is local, multi-center, prospective, cohort study to collect real world data related mCRPC patients, prevalence of HRRm and to assess possible influence of HRRm on treatment outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HRRm mCRPC
- How many people
- 331 participants
- Where
- 14 sitesRussia
- Study dates
- 23 Oct 2020to 30 Sep 2022
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will consist of mCRPC patients with available medical history and FFPE specimen of archival tissue from primary prostate tumor and who received at least one line of therapy for mCRPC or is currently receiving this therapy. It is estimated that 300 patients will be enrolled (this sample can be further increased after the interim analysis based on the actual number of NGS failures). It is estimated that approximately 30 sites in total will be participating in the study. There will be 2 cohorts of patients: HRRm and HRRwt to reveal possible differences in treatment pattern, demographic and clinical characteristics and outcomes in mCRPC patients with and without HRRm.
Who may be able to join
- Male 18 years age or older
- Provision of written informed consent
- Histologically confirmed diagnosis of prostate cancer
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC)
- Patients who are on the first line therapy or already received one line of therapy due to mCRPC previously
- Availability of archival FFPE tissue from primary prostate tumor
- Availability of medical history (e.g. out-patient medical records or disease histories for hospitalized patients)
Who cannot join
- Patients participating in clinical studies
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Research Site
Barnaul, Altayskiy Kray
Research Site
Chelyabinsk, Chelyabinsk Oblast
Research Site
Krasnoyarsk, Krasnoyarsk Krai
Research Site
Moscow
Research Site
Nizhny Novgorod, Nizhniy Novgorod Region
Research Site
Omsk, Omsk Oblast
Research Site
Saint Petersburg, Leningradskaya Oblast'
Research Site
Saint Petersburg
Research Site
Tyumen, Tyumen Oblast
Research Site
Ufa, Bashkortostan Republic
Research Site
Vladivostok, Primorskiy (Maritime) Kray
Research Site
Yaroslavl, Yaroslavl Oblast
Research Site
Yekaterinburg, Sverdlovsk Oblast
Research Site
Yuzhno-Sakhalinsk, Sakhalin Oblast
About this study
Official title: A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)
Study design:
This study is local, multi-center, prospective, cohort study to collect real world data related mCRPC patients, prevalence of HRRm and to assess possible influence of HRRm on treatment outcomes. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Read more
Data Source(s):
For testing archival samples (formalin fixed and paraffin embedded [FFPE]) from primary tumor will be used . 15 HRR genes (BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D and RAD54L) will be analyzed using NGS in dedicated central laboratory facilities. Choice of laboratory for each center will be made based on logistical proximity. Each NGS laboratory will have to determine and report clinical significance of alterations found using database search or other predictors to classify variants as deleterious or suspected deleterious. VUS have to be reported separately. Benign variants will be not reported in this study.
All clinical and demographic data for patients with finished therapy will be collected in prospective or retrospective (where applicable) manner during the study visits. The second visit will take place when the disease progression or death is occurs or in a year after the first visit whichever happens first. Data will be entered in the eCRF. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization.
It is estimated that approximately 300 patients will be enrolled in the first stage. After interim analysis total number of the patients can be increased, depending on the number of NGS failures. It is estimated that approximately 30 sites in total will be participating in the study.
- Conditions
- HRRm mCRPC
- Keywords
- HRRm mCRPC
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in demographics between patients with HRRm and HRRwt mCRPC
Measured: Up to 1 year
Differences in treatment patterns between patients with HRRm and HRRwt mCRPC
Measured: Up to 1 year
Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC
Measured: Up to 1 year
Progression-free survival (PFS) rate (time to documentation of objective tumor progression/relapse) stratified by tissue HRR-related gene mutation status and by treatment pattern
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start23 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HRRm mCRPCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712890
- Sponsor's protocol ID
- D133HR00008
- Acronym
- ADAM
- Status last verified
- Sep 2023
- First submitted
- 8 Jan 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)
- ClinicalTrials.gov ID
- NCT04712890
- Acronym / sponsor ID
- ADAM / D133HR00008
- Conditions
- HRRm mCRPC
- Keywords
- HRRm mCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Jan 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.
Study design:
This study is local, multi-center, prospective, cohort study to collect real world data related mCRPC patients, prevalence of HRRm and to assess possible influence of HRRm on treatment outcomes. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Data Source(s):
For testing archival samples (formalin fixed and paraffin embedded [FFPE]) from primary tumor will be used . 15 HRR genes (BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D and RAD54L) will be analyzed using NGS in dedicated central laboratory facilities. Choice of laboratory for each center will be made based on logistical proximity. Each NGS laboratory will have to determine and report clinical significance of alterations found using database search or other predictors to classify variants as deleterious or suspected deleterious. VUS have to be reported separately. Benign variants will be not reported in this study.
All clinical and demographic data for patients with finished therapy will be collected in prospective or retrospective (where applicable) manner during the study visits. The second visit will take place when the disease progression or death is occurs or in a year after the first visit whichever happens first. Data will be entered in the eCRF. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization.
It is estimated that approximately 300 patients will be enrolled in the first stage. After interim analysis total number of the patients can be increased, depending on the number of NGS failures. It is estimated that approximately 30 sites in total will be participating in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will consist of mCRPC patients with available medical history and FFPE specimen of archival tissue from primary prostate tumor and who received at least one line of therapy for mCRPC or is currently receiving this therapy. It is estimated that 300 patients will be enrolled (this sample can be further increased after the interim analysis based on the actual number of NGS failures). It is estimated that approximately 30 sites in total will be participating in the study. There will be 2 cohorts of patients: HRRm and HRRwt to reveal possible differences in treatment pattern, demographic and clinical characteristics and outcomes in mCRPC patients with and without HRRm.
Key inclusion criteria (7 listed)
- Male 18 years age or older
- Provision of written informed consent
- Histologically confirmed diagnosis of prostate cancer
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC)
- Patients who are on the first line therapy or already received one line of therapy due to mCRPC previously
Key exclusion criteria (1 listed)
- Patients participating in clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in demographics between patients with HRRm and HRRwt mCRPC
Time frame: Up to 1 year
Differences in treatment patterns between patients with HRRm and HRRwt mCRPC
Time frame: Up to 1 year
Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC
Time frame: Up to 1 year
Progression-free survival (PFS) rate (time to documentation of objective tumor progression/relapse) stratified by tissue HRR-related gene mutation status and by treatment pattern
Time frame: Up to 1 year
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 28 Sep 2023.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HRRm mCRPC, run by AstraZeneca at 14 sites in Russia.
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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. 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?
Differences in demographics between patients with HRRm and HRRwt mCRPC (time frame: Up to 1 year). The study lists 4 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 28 Sep 2023.