Safety, efficacy, and pharmacokinetics of Goserelin 3.6 mg depot administered intramuscularly or subcutaneously in subjects with advanced prostate cancer: A Randomized, Open-label, Comparative, Active-controlled, Multicentric, Parallel-groups Study.

Sun Pharma Advanced Research Company Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Histologically/ cytologically confirmed diagnosis of locally advanced (T3, T4) or
•metastatic (M1) adenocarcinoma of the prostate.
•- Serum testosterone levels within normal limits (250-1500 ng/dl) at screening.
•-ECOG performance status of 0-2.
•-Estimated life expectancy of at least 6 months.
•-Adequate renal function: serum creatinine <2.0 mg/dlHistologically/ cytologically confirmed diagnosis of locally advanced (T3, T4) or metastatic (M1) adenocarcinoma of the prostate.
•- Age more than 18 years
•- Serum testosterone levels within normal limits (250-1500 ng/dl) at screening

•History of drug hypersensitivity to LHRH, LHRH agonists or any excipients of the study medication (Test, Reference).
•Participation in another clinical study within the last thirty (30) days prior to the planned first medication administration or during this study.
•Previously treated with orchiectomy, hypophysectomy or adrenalectomy.
•Use of any investigational drug or device within 3 months before study entry.
•Subjects with anticipated problems for compliance with the planned follow-up visits for this protocol, in the opinion of the investigator.
•Subjects with any symptoms or diseases, which could interfere with the evaluation of local tolerance of the study medication at the injection site (e.g. immunization, flu vaccination, etc).
•Active hepatitis, HIV positive.
•Active bacterial or viral infection.
•Subjects who have not recovered from reversible side effects of previous surgery, chemotherapy or radiation therapy.
•Any psychiatric or mental disease compromising the ability to give the consent for participation in the study.

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