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

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.

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 Overview

• Status: Completed
• Conditions: HRRm mCRPC

• Study Type: Observational
• Enrollment (Actual): 331

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Research Site
  • Saint Petersburg, Russian Federation
    • Research Site
  • Altai Krai
    • Barnaul, Altai Krai, Russian Federation
      • Research Site
  • Chelyabinsk Region
    • Chelyabinsk, Chelyabinsk Region, Russian Federation
      • Research Site
  • Krasnoyarsk Krai
    • Krasnoyarsk, Krasnoyarsk Krai, Russian Federation
      • Research Site
  • Leningrad Region
    • Saint Petersburg, Leningrad Region, Russian Federation
      • Research Site
  • Nizhniy Novgorod Region
    • Nizhniy Novgorod, Nizhniy Novgorod Region, Russian Federation
      • Research Site
  • Omsk Region
    • Omsk, Omsk Region, Russian Federation
      • Research Site
  • Primorsky Krai
    • Vladivostok, Primorsky Krai, Russian Federation
      • Research Site
  • Republic Of Bashkortostan
    • Ufa, Republic Of Bashkortostan, Russian Federation
      • Research Site
  • Sakhalin Region
    • Yuzhno-Sakhalinsk, Sakhalin Region, Russian Federation
      • Research Site
  • Sverdlovsk Region
    • Yekaterinburg, Sverdlovsk Region, Russian Federation
      • Research Site
  • Tyumen Region
    • Tyumen, Tyumen Region, Russian Federation
      • Research Site
  • Yaroslavl Region
    • Yaroslavl, Yaroslavl Region, Russian Federation
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences in demographics between patients with HRRm and HRRwt mCRPC	Up to 1 year
Differences in treatment patterns between patients with HRRm and HRRwt mCRPC	Up to 1 year
Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC	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	Up to 1 year

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: HRRm mCRPC
• Other Study ID Numbers: D133HR00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing 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.
• IPD Sharing 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.