A study of Goserelin 10.8 mg Injection in comparison with the drug ZOLADEX® 10.8 mg Injection in patients with prostate cancer.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2020/02/023211
- Lead Sponsor
- Eurofarma Laboratrios SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
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.
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
disease.
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
deposits.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation and comparision of the pharmacodynamics of test product against <br/ ><br>reference product and establish non-inferiority.Timepoint: Pre-dose and Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 43, day 57, day 71, day 85 day 86, day 89, day 99, day 113, day 127, day 141, day 155 and day 169 hours post dose <br/ ><br>
- Secondary Outcome Measures
Name Time Method Evaluation of the pharmacokinetic and safety of <br/ ><br>the test product as compared to reference <br/ ><br>product.Timepoint: For pharmacokinetic <br/ ><br> <br/ ><br>Pre-dose and at <br/ ><br>Day 1, Day 2, Day 3, <br/ ><br>Day 6, Day 9, Day 13, Day 17, Day 22, Day 29, Day 36, Day 43, Day 50, Day 60, Day 71 and Day 85 hours post-dose