NCT03061643

An Open Label Phase II Study of Biweekly Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

SAMSUNG MEDICAL CENTER

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

Detailed description

Although surgical or medical castration is considered standard treatment in hormone-naïve PC patients, some patients with extensive metastatic disease, including visceral or bone involvement beyond axial skeleton, have shorter survival. Based on the recent randomized trials (CHAARTED, GETUG-AFU15 and STAMPEDE), hormone-naïve men with metastatic, high-volume PC should be offered docetaxel plus ADT. However, side effects from standard 3-weekly 75 mg/m2 docetaxel can be substantial. In addition, a prospective trial is needed to determine whether early docetaxel chemotherapy in combination with ADT is beneficial in Korean men. Considering our own experiences with docetaxel, a dose intensity of 20 mg/m2/week (equivalent to 60 mg/m2 3-weekly or 40 mg/m2 biweekly) should be tested in the prospective trial.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
DRUG	Docetaxel	docetaxel 40 mg/m2 IV every 2 weeks plus ADT
OTHER	Androgen-Deprivation Therapy (ADT)	docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Timeline

• Start date: 2017-02-08
• Primary completion: 2022-03-01
• Completion: 2022-06-01
• First posted: 2017-02-23
• Last updated: 2022-03-08

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study