Clinical trial NCT04425200: Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
Official title: Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: metastatic castration resistant prostate cancer, BRCA1, BRCA2, ATM, Homologous recombination repair
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 205
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is mCRPC patients who diagnosed between 2014 and 2018 and be confirmed to be succeeded HRR-related gene mutation analysis with archived primary or metastatic tumor sample. As median of expected overall survival of mCRPC is 2.5 to 3 years from diagnosis, follow up period is enough to measure outcomes including survival. The baseline period is set to calculate overall survival and to detect clinical outcome at least half. The patients will be enrolled consecutively to this study.

Brief summary: The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients.

\<Methods\> Study design: multi-center, prospective cohort study

Data Source(s):

In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern

Sample Size Estimations:

The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).

Statistical Analysis:

This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.


Eligibility criteria: Inclusion Criteria:

* Age \> 20, Japanese men at the time of informed consent.
* Patients who provided informed consent. If the patient has died, opt-out will be applicable.
* Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018.
* Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution.
* Patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test.

Exclusion Criteria:

* Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period.
* Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin.
* Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.

Primary outcomes:
measure: Prevalence of tissue HRR-related gene mutations
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of each treatment pattern
timeFrame: From index date(diagnosed as mCRPC) patients to December 31 2020
Other outcomes:
measure: Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients
timeFrame: Baseline
measure: PSA50 response
timeFrame: From index date(diagnosed as mCRPC) to december 31 2020
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Kashiwa
country: Japan
facility: Jikei University Kashiwa Hospital
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Miki
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
References: