A clinical trial to study the safety, efficacy and pharmacokinetics of Goserelin acetate in subjects with advanced prostate cancer.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000283

Enrollment

Registered

2010-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: null- Patients with advanced prostate cancer

Interventions

Intervention1: Goserelin acetate 3.6 mg intramuscular depot injection: At 28-day intervals (4 weeks) for 8 weeks Control Intervention1: Goserelin acetate&reg

3.6 mg subcutaneous depot injection: At 28-day intervals (4 weeks) for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: - 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 - Age more than 18 years - Serum testosterone levels within normal limits (250-1500 ng/dl) at screening

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with a total serum testosterone concentration &#8804; 50ng/dl at day 29 (week 5) after each dose.Timepoint: Prospective	—

Secondary

Measure	Time frame
Changes in AP levelTimepoint: Prospective;Changes in LH levelTimepoint: Prospective;Changes in PSA levelTimepoint: Prospective;Changes in testosterone levelTimepoint: Prospective	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com912266455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026