A clinical study comparing Relugolix and Leuprolide in men with advanced prostate cancer to evaluate which treatment offers better safety, effectiveness.

A Randomized Blinded Parallel Group Study To Evaluate The Safety And Efficacy Of Relugolix In Advanced Prostate Cancer. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088328

Enrollment

Registered

2025-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Interventions

Intervention1: Tab RELUGOLIX 120 mg OD: Tab RELUGOLIX 360 mg loading dose on day 1, followed by 120 mg OD for 6 months. Control Intervention1: Injection LEUPROLIDE 22.5 mg every 3 Months.: Injection L

Eligibility

Inclusion criteria

Inclusion criteria: 1.Men aged more than 18 years 2.Diagnosed with advanced prostate cancer (metastatic or locally advanced) and eligible for androgen deprivation therapy. 3.Histologically confirmed prostate adenocarcinoma. 4.ECOG performance status less than or equal to 3. 5.No prior treatment or not at least 3 months with chemotherapy

Exclusion criteria

Exclusion criteria: 1. Any hypersensitivity to relugolix or any of its components. 2. Prior history of other malignancies within the last 5 years (except basal cell carcinoma or superficial bladder cancer). 3. Known presence of significant cardiac arrhythmias or history of thromboembolic events

Design outcomes

Primary

Measure	Time frame
Efficacy measured by changes in components of 4K score (total and free PSA) levels over time from baseline at a predetermined time point in 6 months.Timepoint: 3 and 6 months	—

Secondary

Measure	Time frame
Progression-free survival (PFS): based on clinical assessments of components of 4K score levels.Timepoint: 3 and 6 months.;Safety profile: Use the Common Terminology Criteria for Adverse Events-5 (CTCAE-5) to determine the frequency of adverse events (AEs) and serious adverse events (SAEs) and toxicities.Timepoint: 3 and 6 months;Change in Quality of Life (QoL) Scores: Assess the impact of treatment on patients overall well-being and specific aspects of health-related quality of life using validated questionnaires (FACT-P) at baseline and at specified intervals during the treatment.Timepoint: 0,3,6 months	—

Measure

Time frame

Progression-free survival (PFS): based on clinical assessments of components of 4K score levels.Timepoint: 3 and 6 months.;Safety profile: Use the Common Terminology Criteria for Adverse Events-5 (CTCAE-5) to determine the frequency of adverse events (AEs) and serious adverse events (SAEs) and toxicities.Timepoint: 3 and 6 months;Change in Quality of Life (QoL) Scores: Assess the impact of treatment on patients overall well-being and specific aspects of health-related quality of life using validated questionnaires (FACT-P) at baseline and at specified intervals during the treatment.Timepoint: 0,3,6 months

—

Countries

India

Contacts

Public ContactShwetaben Laxmanbhai Borkhataria

Associate Professor, Department of Pharmacology, AIIMS Bathinda

mpal24@yahoo.com7002351928

Outcome results

None listed

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