Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer

NCT03936218 | Completed Phase 3 DMC

• 1 other identifier: EF 161
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority.

  Proportion of patients achieving castrate level of serum testosterone (Serum testosterone ≤ 0.5 ng/ml) at the end of 24 weeks

  24 weeks

Study Arms (2)

Inj. Goserelin (Test) Subcutaneously

EXPERIMENTAL

10.8 mg, Subcutaneously at every 3 month

Drug: Inj. Goserelin (Test) Subcutaneously

Inj. Zoladex (Reference) Subcutaneously

ACTIVE COMPARATOR

10.8 mg, Subcutaneously at every 3 month

Drug: Inj. Zoladex (Reference) Subcutaneously

Interventions

Inj. Goserelin (Test) Subcutaneously DRUG

10.8 mg, subcutaneously at every 3 month

Also known as: Goserelin

Inj. Goserelin (Test) Subcutaneously

Inj. Zoladex (Reference) Subcutaneously DRUG

10.8 mg, Subcutaneously at every 3 month

Also known as: Zoladex

Inj. Zoladex (Reference) Subcutaneously

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 2.
• 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:
• Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1)
• Barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom)
• Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner). If the patient becomes sexually active during the study, then he is required to use a double barrier method of contraception.

You may not qualify if:

• 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.
• Patients with a clinically significant medical condition other than advanced prostate cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.
• Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
• History of orchiectomy, adrenalectomy or hypophysectomy.
• Patients receiving anticoagulation medications.
• Patients with uncontrolled diabetes mellitus (HbA1c \> 8 % as per ADA) at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Mahatma Gandhi Cancer Hospital & Research Institute

Visakhapatnam, Andhra Pradesh, 530017, India

Location

MeSH Terms

Interventions

Goserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 3, 2019
• Study Start: September 30, 2020
• Primary Completion: November 30, 2023
• Study Completion: April 1, 2024
• Last Updated: April 17, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)