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A single-arm exploratory trail of combination of abiraterone with daidzein in the treatment of castration resistant prostate cancer

The clinical study of combination of abiraterone with daidzein in the treatment of castration resistant prostate cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034019
Enrollment
Unknown
Registered
2020-06-21
Start date
2020-06-24
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

prostate cancer

Interventions

experimental group:abiraterone+daidzein+prednisone

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients over the age of 18 who signed the informed consent. 2) Prostate adenocarcinoma was confirmed by histology or cytology. 3) Patients were castrated resistant prostate cancer patients (serum testosterone =12 months. 7) Patients were able to swallow the study drug and comply with the study requirements. 8) Patients agree to use condoms and other effective contraceptive methods having sex with a fertile woman. 9) Patients agreed not to participate in other intervention studies during the treatment period.

Exclusion criteria

Exclusion criteria: 1) Patients had a history of other aggressive cancer within 3 years before screening. 2) At the time of screening, total bilirubin >= 1.5 * normal upper limit or alanine aminotransferase >= 2.5 * normal upper limit. 3) The creatinine of the subjects was more than 442 umol / L at the time of screening. 4) Subjects were in active infection or other medical conditions in which prednisone was contraindicated. 5) At the time of screening, the patients had uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg for at least two consecutive blood pressure measurements).

Design outcomes

Primary

MeasureTime frame
progression free survial;

Secondary

MeasureTime frame
objective response rate;overall survival;PSA decrease range;bone events;

Countries

China

Contacts

Public ContactWu Denglong

Shanghai Tongji Hospital

wudenglong2009@tongji.edu.cn+86 021-66111532

Outcome results

None listed

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