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Exploring the value of NGS for efficacy prediction in treatment of high-risk mCRPC patients with abiraterone and analyzing drug resistance mechanisms

Exploring the value of NGS for efficacy prediction in treatment of high-risk mCRPC patients with abiraterone and analyzing drug resistance mechanisms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026647
Enrollment
Unknown
Registered
2019-10-17
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

prostate cancer

Interventions

single arm:abiraterone

Sponsors

Renji Hospital, Shanghai Jiaotong University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) According to the EAU-ESTRO-SIOG 2016 guidelines, the clinical diagnosis is mCRPC; 2) Patients with poor prognosis mCRPC, defined as (2019ASCO abs5003): liver metastasis, or progression to CRPC within 12 months of ADT treatment, or >= 4 in the following prognostic features (LDH>ULN; ECOG PS 2; visceral metastasis) ; AlbuminULN; starting at ADT = 3000/mm3 or absolute neutrophil count >= 1500/mm3, AST and ALT are lower than 1.5 ULN; 9) When signing the informed consent form, the age is equal to or greater than 18 years old and less than 75 years old; 10) The investigator expects the patient to survive for more than 3 months; 11) Patients agree and have the ability to follow planned study visits, provide blood samples before and after treatment, provide clinical information and coordinate with other research steps.

Exclusion criteria

Exclusion criteria: 1) The investigator judges that the patient has other serious diseases that may affect follow-up and short-term survival, and any medical reasons show a significant risk of death during the 1-year study period; 2) Previous diagnosis of any other malignant tumor; 3) There are other malignant tumors at the same time; 4) The clinical information required for the study cannot be obtained (eg, the patient is lost); 5) Other investigators believe that it is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
overall survival;PSA response;quality of life;

Countries

China

Contacts

Public ContactWei Xue

Renji Hospital, Shanghai Jiaotong University School of Medicine

uroxuewei@163.com+86 13801931604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026