HRRm mCRPC Clinical Trial
— ADAMOfficial title:
A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)
| Verified date | September 2023 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 331 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | September 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Site | Barnaul | Altai Krai |
| Russian Federation | Research Site | Chelyabinsk | Chelyabinsk Region |
| Russian Federation | Research Site | Krasnoyarsk | Krasnoyarsk Krai |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | Nizhniy Novgorod Region |
| Russian Federation | Research Site | Omsk | Omsk Region |
| Russian Federation | Research Site | Saint Petersburg | Leningrad Region |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Tyumen | Tyumen Region |
| Russian Federation | Research Site | Ufa | Republic Of Bashkortostan |
| Russian Federation | Research Site | Vladivostok | Primorsky Krai |
| Russian Federation | Research Site | Yaroslavl | Yaroslavl Region |
| Russian Federation | Research Site | Yekaterinburg | Sverdlovsk Region |
| Russian Federation | Research Site | Yuzhno-Sakhalinsk | Sakhalin Region |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in demographics between patients with HRRm and HRRwt mCRPC | Up to 1 year | ||
| Primary | Differences in treatment patterns between patients with HRRm and HRRwt mCRPC | Up to 1 year | ||
| Primary | Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC | Up to 1 year | ||
| Primary | 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 |