Clinical trial NCT04712890: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HRRm mCRPC
Keywords: HRRm mCRPC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Differences in demographics between patients with HRRm and HRRwt mCRPC
timeFrame: Up to 1 year
measure: Differences in treatment patterns between patients with HRRm and HRRwt mCRPC
timeFrame: Up to 1 year
measure: Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Research Site
state: Altai Krai
city: Chelyabinsk
country: Russian Federation
facility: Research Site
state: Chelyabinsk Region
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
state: Krasnoyarsk Krai
city: Saint Petersburg
country: Russian Federation
facility: Research Site
state: Leningrad Region
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
state: Nizhniy Novgorod Region
city: Omsk
country: Russian Federation
facility: Research Site
state: Omsk Region
city: Vladivostok
country: Russian Federation
facility: Research Site
state: Primorsky Krai
city: Ufa
country: Russian Federation
facility: Research Site
state: Republic Of Bashkortostan
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
state: Sakhalin Region
city: Yekaterinburg
country: Russian Federation
facility: Research Site
state: Sverdlovsk Region
city: Tyumen
country: Russian Federation
facility: Research Site
state: Tyumen Region
city: Yaroslavl
country: Russian Federation
facility: Research Site
state: Yaroslavl Region
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
Study officials:
References: