Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Docetaxel

Carboplatin

Hormones

Cisplatin

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.

Docetaxel alone will be applied every 3 weeks for 6 cycles.

Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.

5mg Prednisolone Acetate will be given orally twice a day during treatment.

Prednisolone Acetate

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.

Platinum-based drugs

Shun Zhang, MD

Hongqian Guo, MD

Shun Zhang

Hongqian Guo

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.

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

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.

The survival rate of participants during follow-up time.

Radiographic progression-free survival. The survival of participants without radiographic progression.

PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.

Time from end of treatment to the time when subsequent anti-tumor therapy is needed.

All grades of adverse events will be recorded according to NCI CTCAE (v.5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer	NCT05461261	Hormone Sensiti... DNA Damage Repa... Chemotherapy Ef... Chemotherapeuti...	Docetaxel Prednisolone Ac... Platinum-based ...	40 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer	NCT05461261	Hormone Sensiti... DNA Damage Repa... Chemotherapy Ef... Chemotherapeuti...	Docetaxel Prednisolone Ac... Platinum-based ...	40 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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