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

Outcome of treatment for castration-resistant prostate cancer with homologous recombination repair-related gene mutations (multiinstitutional prospective observational study). - HRRCAP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1050230026

Enrollment

400

Registered

2023-05-23

Start date

2022-11-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate cancer

Interventions

none

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactTakayuki Goto

Kyoto University Hospital

goto@kuhp.kyoto-u.ac.jp+81-75-751-3337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026