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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel plus platinum | Experimental | Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles. |
|
| Docetaxel alone | Active Comparator | Docetaxel alone will be applied every 3 weeks for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The survival rate of participants during follow-up time. | up to 5 years |
| rPFS | Radiographic progression-free survival. The survival of participants without radiographic progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Zhang, MD | Contact | 15050589789 | explorershun@126.com | |
| Hongqian Guo, MD | Contact | dr.ghq@nju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo | Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University Locations: China, Jiangsu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Prednisolone Acetate | Drug | 5mg Prednisolone Acetate will be given orally twice a day during treatment. |
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| Platinum-based drugs | Drug | 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. |
|
| up to 5 years |
| Time to PSA progression | PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart. | up to 5 years |
| Time to subsequent anti-tumor therapy | Time from end of treatment to the time when subsequent anti-tumor therapy is needed. | up to 5 years |
| Adverse events | All grades of adverse events will be recorded according to NCI CTCAE (v.5.0) | up to 3 years |
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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