Trials / Unknown
UnknownNCT05461261
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- Male
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
Conditions
- Hormone Sensitive Metastatic Prostate Cancer
- DNA Damage Repair Deficiency
- Chemotherapy Effect
- Chemotherapeutic Toxicity
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles. |
| DRUG | Prednisolone Acetate | 5mg Prednisolone Acetate will be given orally twice a day during treatment. |
| DRUG | Platinum-based drugs | Platinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles. Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance. |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2025-06-30
- Completion
- 2025-12-31
- First posted
- 2022-07-18
- Last updated
- 2022-10-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05461261. Inclusion in this directory is not an endorsement.