A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT02726009
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Study Start: 2016-05
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 230

Inclusion Criteria

• Has given written informed consent before any study-related activity is performed
• Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
• Age greater than or equal to 18 years and less than 80 years
• Advanced hormone-dependent prostate cancer without any other clinically significant disorder
• Easten Cooperative Oncology Group score ≤ 2
• PSA ≥ 2 ng/mL at screening
• Life expectancy of at least 12 months as per the investigator's judgement

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Exclusion Criteria

• Previous or concurrent hormonal management of prostate cancer
• Contraindication for prescription of Firmagon®
• Concurrent treatment with a 5-α-reductase inhibitor
• Considered as a candidate for curative therapy
• History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
• QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
• Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
• Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
• Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
• Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Degarelix	Degarelix	-

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events	Up to Day 364
Severity of adverse events	Up to Day 364
Clinically significant changes in laboratory values (hematology and clinical biochemistry)	From baseline to Day 364
Clinically significant changes in vital signs	From baseline to Day 364

Secondary Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Score (IPSS)	From baseline to Day 364
Change in physician's satisfaction score	From baseline to Day 364
Cumulative probability of no Prostate Specific Antigen (PSA) failure	Up to Day 364	PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart
Cumulative probability of Progression Free Survival (PFS)	Up to Day 364	PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first

Trial Locations

Locations (19)

Shalby Hospital; 🇮🇳 Ahmedabad, India

HealthCare Global Enterprises Limited; 🇮🇳 Bangalore, India

Bodyline Hospitals; 🇮🇳 Ahmedabad, India

Krishna Institute of Medical Sciences; 🇮🇳 Secunderabad, Telangana, India

KLE's Dr. Prabhakar Kore Hospital & MRC; 🇮🇳 Belgaum, India

Apollo Speciality Hospital; 🇮🇳 Chennai, India

Muljibhai Patel Urological Hospital; 🇮🇳 Gujrat, India

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 Delhi, India

Rml & Pgimer; 🇮🇳 New Delhi, India

SMS Medical College & Attached Hospital's; 🇮🇳 Jaipur, India

S. P Medical College and AG of Hospitals; 🇮🇳 Bikaner, Rajasthan, India

HCG Multi Specialty Hospital; 🇮🇳 Ahmedabad, India

CHL Hospital; 🇮🇳 Indore, India

Tata Medical Center; 🇮🇳 Kolkata, India

Government Medical College and Super Specialty Hospital; 🇮🇳 Nagpur, India

Aman Hospital and Research Center; 🇮🇳 Vadodara, India

King's George Medical University; 🇮🇳 Lucknow, India

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute; 🇮🇳 Mumbai, India

Tata Memorial Hospital; 🇮🇳 Mumbai, India