Effectiveness, pharmacokinetics, and safety of triptorelin acetate microspheres in patients with locally advanced and metastatic prostate cancer.

ABSTRACT:

Background

A newly generic microspheres, sustained-release formulation of triptorelin acetate 3.75 mg has been developed.

Objectives

To evaluate the efficacy, pharmacokinetics, and safety of triptorelin 1-month formulation in Chinese patients with prostate cancer.

Design

An open-label, multicenter clinical trial with one arm testing a 1-month sustained-release triptorelin formulation in prostate cancer patients.

Methods

Patients with prostate cancer received three consecutive 28-day injections of triptorelin acetate. The primary endpoint was the proportion of successful patients over the total number of evaluable patients. Treatment success was defined as testosterone suppression below the clinical castration level (i.e., <0.5 ng/mL) at day 28 and maintenance o

SUBMITTER: Wu G 

PROVIDER: S-EPMC11672368 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature