A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Subcutaneous Goserelin 10.8mg Injection (Sponsor) With ZOLADEX® 10.8mg Injection (AstraZeneca) in Patients With Advanced Prostate Cancer

Eurofarma Laboratorios S.A.1 site in 1 country94 target enrollmentSeptember 30, 2020

ConditionsAdvanced Prostate Cancer

InterventionsInj. Goserelin (Test) Subcutaneously Inj. Zoladex (Reference) Subcutaneously

DrugsInj. Goserelin (Test) Subcutaneously Inj. Zoladex (Reference) Subcutaneously

Overview

Phase: Phase 3
Intervention: Inj. Goserelin (Test) Subcutaneously
Conditions: Advanced Prostate Cancer
Sponsor: Eurofarma Laboratorios S.A.
Enrollment: 94
Locations: 1
Primary Endpoint: To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.

Detailed Description

A phase III, two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer. Each patient will have 25 visits total. Total duration of the study will be 183 days (including up to 14 days of screening).

Registry

clinicaltrials.gov

Start Date

September 30, 2020

End Date

April 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eurofarma Laboratorios S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male patient with age of 18 to 75 years (Both inclusive)
•Body mass index (BMI) between 18.5 and 30 kg/m². (Both inclusive)
•Patient with a confirmed advanced prostatic adenocarcinoma. (TNM stage III or IV or recurrent metastatic disease) who are scheduled to start Goserelin therapy as per Investigator discretion. Note: Stage III (T1-T2, N0, M0, PSA level is 20 or more, Grade Group 1-4 or T3--T4, N0, M0, any PSA, Grade Group 1-4 or any T, N0, M0, any PSA, Grade Group 5). Stage IV (any T, N1, M0, any PSA, any Grade Group or any T, N0, M1, any PSA, any Grade Group)
•Serum testosterone level \>2.5 ng/mL for age of 20 to 49 (both inclusive) and \>1.9 ng/mL for age ≥ 50 at screening. (Screening sample for Serum testosterone level should be taken before 10:00 am in the morning).
•Patient must be able to give informed consent for participation in the trial.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•Adequate bone marrow function, renal function, liver function.
•Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
•Patients with life expectancy of at least 1 year as judged by the Investigator.
•Patient or his partner willing to use an effective method as mentioned below of contraception during the study:

Exclusion Criteria

•Evidence of severe urinary tract obstruction with anticipated urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
•Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
•Patients who are already on GnRH receptor agonist or antagonist therapy directed for prostate cancer.
•Patients who have previously failed on GnRH receptor agonist or antagonist therapy for prostate cancer.
•Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree (proven or suspected) of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymhangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
•Patients who are intended to be started on any medication apart from study drug that can have impact on any of the study endpoints.
•Patients with spinal cord compression (in the opinion of the Investigator), taking into account medical history, clinical observations and symptoms.
•Excruciating, severe bone pain which is due to extensive metastatic osseous deposits.
•Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy \>5 years previously and have no known evidence of residual or recurrent disease.
•Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically confirmed brain metastasis.