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The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer

NCT05461261 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-10-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Hongqian Guo · Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University Locations: China, Jiangsu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461261 on ClinicalTrials.gov