Prostatic Neoplasms
Conditions
Keywords
metastatic castration resistant prostate cancer, BRCA1, BRCA2, ATM, Homologous recombination repair
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of tissue HRR-related gene mutations | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of each treatment pattern | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients | Baseline | Patient's characteristics will be summarized. |
| PSA50 response | 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. |
Countries
Japan
Outcome results
None listed