CTRI/2020/02/023211Not yet recruitingPhase 3
A phase III, two arm, multi centric, randomised, open label, parallel study to compare pharmacodynamics ofGoserelin 10.8 mg Injection (Eurofarma Laboratórios S.A) administered subcutaneously with the referencedrug ZOLADEX® 10.8 mg Injection (AstraZeneca) in patients with advanced prostate cancer.
Eurofarma Laboratrios SA0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male patient with age of 18 to 75 years (Both inclusive)
- •2. Body mass index (BMI) between 18.5 and 30 kg/m². (Both inclusive)
- •3. 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
- •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)
- •4. 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).
- •5. Patient must be able to give informed consent for participation in the trial.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •7. Adequate bone marrow function, renal function, liver function.
- •8. Patient should have recovered from any toxic effects of previous chemotherapy as
- •judged by the Investigator.
- •9. Patients with life expectancy of at least 1 year as judged by the Investigator.
- •10. Patient or his partner willing to use an effective method as mentioned below of
- •contraception during the study:
- •a) 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)
- •b) Barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal
- •spermicide, female condom, or male condom)
- •c) 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.
Exclusion Criteria
- •1. 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.
- •2. Patients who are scheduled to receive any chemotherapy/radiotherapy in addition
- •to goserelin.
- •3. Patients who are already on GnRH receptor agonist or antagonist therapy directed
- •for prostate cancer.
- •4. Patients who have previously failed on GnRH receptor agonist or antagonist
- •therapy for prostate cancer.
- •5. 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
- •6. Patients who are intended to be started on any medication apart from study drug
- •that can have impact on any of the study endpoints.
- •7. Patients with spinal cord compression (in the opinion of the Investigator), taking
- •into account medical history, clinical observations and symptoms.
- •8. Excruciating, severe bone pain which is due to extensive metastatic osseous
- •9. 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.
- •10. Patients with confirmed signs or symptoms related to cerebral metastasis or
- •radiographically confirmed brain metastasis.
- •11. 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.
- •12. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any
- •of the components in IMP.
- •13. History of orchiectomy, adrenalectomy or hypophysectomy.
- •14. Patients receiving anticoagulation medications.
- •15. Patients with uncontrolled diabetes mellitus (HbA1c > 8 % as per ADA) at
- •randomization (those who have controlled blood sugar (fasting) will be eligible
- •for randomization)
- •16. 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).
- •17. Patients with a QTc >450ms on the ECG at screening.
- •18. History of clinically significant cardiovascular disorder.
- •19. 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.
- •20. Concomitant use of medicinal products known to prolong the QT interval or <br
Investigators
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