Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting

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.

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Key information

Conditions

Prostatic Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fanconi Anemia, Complementation Group D1 Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Prevalence of tissue HRR-related gene mutations

Time frame: Baseline

Calculate number and prevalence of each HRR-related gene mutation status (Positive/Negative/VUS), respectively. Prevalence will be accompanied by 95% Clopper-Pearson confidence intervals.

Secondary outcomes

Proportion of each treatment pattern

Time frame: From index date(diagnosed as mCRPC) patients to December 31 2020

The number (%) of patients by treatment pattern in 1st line treatment, 2nd line, and 3rd line treatment after diagnosed as mCRPC, respectively, will be calculated.

Other outcomes

Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients

Time frame: Baseline

Patient's characteristics will be summarized.
PSA50 response

Time frame: From index date(diagnosed as mCRPC) to december 31 2020

PSA50 response will be analysed based on baseline and nadir PSA value in each treatment.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: ZENSHIN

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 11, 2020
Registry last updated: Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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