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Determination of Prevalence and Features of HRRm mCRPC (ADAM) (ADAM)

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ClinicalTrials.gov Identifier: NCT04712890
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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. 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.


Condition or disease
HRRm mCRPC

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022



Primary Outcome Measures :
  1. Differences in demographics between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
  2. Differences in treatment patterns between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
  3. Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

• Patients participating in clinical studies


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712890


Locations
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Russian Federation
Altay regional oncological hospital Not yet recruiting
Barnaul, Russian Federation
Contact: Sergey Varlamov    7-3812-258217    akod@akod22.ru   
Chelyabinsk oncology center Recruiting
Chelyabinsk, Russian Federation
Contact: Galina Gopp    8 (351) 214-88-88    onco74@chelonco.ru   
Sverdlovsk regional oncological hospital Recruiting
Ekaterinburg, Russian Federation
Contact: Aleksandr Orlov    +7 (343) 356-17-31    cood@uralonco.ru   
Moscow city oncological hospital N 2 Recruiting
Moscow, Russian Federation
Contact: Aleksandr Bystrov    7 495 536 01 00    gob62@zdrav.mos.ru   
Privolzhsky regional medical center Recruiting
Nizhniy Novgorod, Russian Federation
Contact: Vagif Adtuev    +7 (831) 428 81 88    pomc@bk.ru   
Clinical oncology hospital of Omsk Recruiting
Omsk, Russian Federation
Contact: Evgeny Kopyltsov    7-3812-258217    minzdrav@minzdrav.omskportal.ru   
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04712890    
Other Study ID Numbers: D133HR00008
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
HRRm mCRPC