Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 8, 2021
First Posted Date January 15, 2021
Last Update Posted Date February 25, 2021
Actual Study Start Date October 23, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2021)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Prevalence and Features of HRRm mCRPC (ADAM)
Official Title A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition HRRm mCRPC
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 13, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04712890
Other Study ID Numbers D133HR00008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date February 2021