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Advanced Prostate CancerPhase 3NCT03936218

Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer

A Phase 3 study testing Inj. Goserelin (Test) Subcutaneously and Inj. Zoladex (Reference) Subcutaneously in people with Advanced Prostate Cancer, run by Eurofarma Laboratorios S.A. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Advanced Prostate Cancer
What is being tested?
Inj. Goserelin (Test) Subcutaneously and Inj. Zoladex (Reference) Subcutaneously
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteIndia
Study dates
30 Sep 2020to 1 Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)
  • Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias. (Patients with hypertension controlled by antihypertensive therapies are eligible).
  • Patients with a QTc>450ms on the ECG at screening.
  • History of clinically significant cardiovascular disorder.
  • Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.
  • Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
  • A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
  • Patients who test positive for HIV and/or syphilis.
  • The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.
  • Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 180 days prior to receiving the first dose of study medicine.
  • Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Mahatma Gandhi Cancer Hospital & Research Institute

    Visakhapatnam, Andhra Pradesh, 530017

Other trials in India

About this study

Official title: 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

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

Read the 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).

Being tested
Inj. Goserelin (Test) Subcutaneously, Inj. Zoladex (Reference) Subcutaneously

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inj. Goserelin (Test) SubcutaneouslyDrug

    Also called Goserelin

    10.8 mg, subcutaneously at every 3 month

  • Inj. Zoladex (Reference) SubcutaneouslyDrug

    Also called Zoladex

    10.8 mg, Subcutaneously at every 3 month

Study groups in NCT03936218
Study groupRoleWhat they receive
Inj. Goserelin (Test) SubcutaneouslyExperimental10.8 mg, Subcutaneously at every 3 month
Receives: Drug: Inj. Goserelin (Test) Subcutaneously
Inj. Zoladex (Reference) SubcutaneouslyActive comparator10.8 mg, Subcutaneously at every 3 month
Receives: Drug: Inj. Zoladex (Reference) Subcutaneously

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start30 Sep 2020
  3. Primary completion30 Nov 2023
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936218
Sponsor's protocol ID
EF 161
Status last verified
May 2024
First submitted
29 Apr 2019
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not yet known if there will be a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inj. Goserelin (Test) Subcutaneously and Inj. Zoladex (Reference) Subcutaneously in people with Advanced Prostate Cancer, run by Eurofarma Laboratorios S.A. at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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