Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

Summary

This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.

Timeline

Start

2017-02-21

Primary completion

2017-12-06

Completion

2018-01-02

Drugs

Indications