CTRI/2020/02/023211
Not yet recruiting
Phase 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 enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Sponsor
- Eurofarma Laboratrios SA
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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