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

An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India
    • Bodyline Hospitals
  • Ahmedabad, India
    • HCG Multi Specialty Hospital
  • Ahmedabad, India
    • Shalby Hospital
  • Bangalore, India
    • Healthcare Global Enterprises Limited
  • Belgaum, India
    • KLE's Dr. Prabhakar Kore Hospital & MRC
  • Chennai, India
    • Apollo Speciality Hospital
  • Delhi, India
    • Rajiv Gandhi Cancer Institute and Research Centre
  • Gujrat, India
    • Muljibhai Patel Urological Hospital
  • Indore, India
    • CHL Hospital
  • Jaipur, India
    • SMS Medical College & Attached Hospital's
  • Kolkata, India
    • Tata Medical Center
  • Lucknow, India
    • King's George Medical University
  • Mumbai, India
    • Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
  • Mumbai, India
    • Tata Memorial Hospital
  • Nagpur, India
    • Government Medical College and Super Specialty Hospital
  • New Delhi, India
    • Rml & Pgimer
  • Vadodara, India
    • Aman Hospital and Research Center
  • Rajasthan
    • Bikaner, Rajasthan, India
      • S. P Medical College and AG of Hospitals
  • Telangana
    • Secunderabad, Telangana, India
      • Krishna Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix	Drug: Degarelix; Other Names: Firmagon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Cumulative probability of no Prostate Specific Antigen (PSA) failure	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	Up to Day 364
Cumulative probability of Progression Free Survival (PFS)	PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first	Up to Day 364
Change in International Prostate Symptom Score (IPSS)		From baseline to Day 364
Change in physician's satisfaction score		From baseline to Day 364

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 000201