Prospective observational study of castration-resistant prostate cancer with homologous recombination repair-related gene mutations.

JRCT ID: jRCT1050230026

Registered date:23/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 02/11/2022
• Target sample size: 400
• Study type: Observational
• Intervention(s): none

Outcome(s)

Primary Outcome

1) Relationship between overall survival and treatment status of CRPC patients with HRR-related gene mutations by mutant gene.
2) Among CRPC patients with HRR-related gene mutations, associations between pathological mutations in the gene (Mutations, copy number changes, and structural polymorphisms) and progression-free and overall survival in patients treated with PARP inhibitors or platinum or immune checkpoint inhibitors.

Secondary Outcome

1) Search for factors independently associated with progression-free survival after integrating the above genetic analysis data with clinical data in cases using PARP inhibitors or platinum drugs or immune checkpoint inhibitors
2) Searching for somatic genetic changes associated with acquisition of treatment resistance in CRPC patients with HRR-related gene mutations who used PARP inhibitors, platinum drugs, and immune checkpoint inhibitors

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Patients with castration-resistant prostate cancer who have mutations in any of the following homologous recombination repair-related genes as a result of germline analysis (BRACAnalysis) or cancer panel testing with all of the following HRR-related 15 genes as targets, and who have agreed to a prospective observational study
Homologous recombination repair gene mutations of interest: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L
2) Patients who have agreed to undergo genetic analysis of their blood before starting treatment and at the time of acquisition of resistance to treatment when using PARP inhibitors or platinum drugs or immune checkpoint inhibitors during prospective observational studies
3) Those who were 20 years of age or older at the time of obtaining consent

Exclude criteria

1) Patients for whom routine follow-up, including imaging, is not possible due to comorbidities or other reasons
2) Other patients deemed unsuitable by the principal investigator or sub-investigator to conduct the study

Related Information

• Primary Sponsor: Goto Takayuki
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd.,Japan Society for the Promotion of Science