NCT05713578

Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:Treatment group 1: apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Detailed description

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan: Treatment group 1: apantamide+docetaxel+ADT Patients were treated with apantamide+docetaxel+ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone. To prevent docetaxel related hypersensitivity and fluid retention, oral administration of 8 mg dexamethasone is recommended 12 hours, 3 hours and 1 hour before infusion of docetaxel.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first. Treatment group 2: apantamide+ADT treatment Patients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Conditions

• Cohort Studies

Interventions

Type	Name	Description
DRUG	apantamide+docetaxel+ADT	Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.
DRUG	apantamide+ADT treatment	apantamide+ADT treatment

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: China