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A prospective observational study evaluating intestinal microbiome as a biomarker to predict the efficacy and toxicity of BRCA1/2 mutant metastatic castration resistant prostate cancer patietns receiveing PARP inhibitors

A prospective observational study evaluating intestinal microbiome as a biomarker to predict the efficacy and toxicity of BRCA1/2 mutant metastatic castration resistant prostate cancer patietns receiveing PARP inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035069
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Prostate Cancer

Interventions

case series:Nil

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed prostate cancer; 2. Metastatic lesions with CT/MRI/bone scan certification and at least one lesion is assessable (according to RECIST1.1) 3. Estimated survival time >= 3 months; 4. Castrated testosterone level and progressed disease at the time of screening; 5. Failed previous treatment with abiraterone and/or enzalutamide (including similar drugs) and failed chemotherapy with docetaxel; 6. Carry pathogenic or likely pathogenic germline and/or somatic BRCA1/2 mutation.

Exclusion criteria

Exclusion criteria: 1. Those who have used other PARP inhibitors in the past; 2. Patients who are clinically judged unsuitable for treatment with PARP inhibitors.

Design outcomes

Primary

MeasureTime frame
ORR;OS;PFS;AE;

Countries

China

Contacts

Public ContactDingwei Ye
dingwei_ye1963@163.com+86 21-64175590

Outcome results

None listed

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