Trials / Unknown
UnknownNCT04356430
Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer
Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abiraterone Acetate | 1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy |
| DRUG | Prednisone | 5 mg oral low dose prednisone, once daily |
| DRUG | Goserelin 10.8 mg | 10.8 mg goserelin hypodermic once per 12 weeks |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2021-03-01
- Completion
- 2023-12-01
- First posted
- 2020-04-22
- Last updated
- 2022-12-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04356430. Inclusion in this directory is not an endorsement.