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Completed

NCT Number: NCT02726009

A Trial to Evaluate Safety of Firmagon® (Degarelix) 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

degarelix

Drug

Other names: Firmagon®

Primary outcomes

  1. Frequency of adverse events

    Time frame: Up to Day 364

  2. Severity of adverse events

    Time frame: Up to Day 364

  3. Clinically significant changes in laboratory values (hematology and clinical biochemistry)

    Time frame: From baseline to Day 364

  4. Clinically significant changes in vital signs

    Time frame: From baseline to Day 364

Secondary outcomes

  1. Cumulative probability of no Prostate Specific Antigen (PSA) failure

    Time frame: 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

  2. Cumulative probability of Progression Free Survival (PFS)

    Time frame: 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

  3. Change in International Prostate Symptom Score (IPSS)

    Time frame: From baseline to Day 364

  4. Change in physician's satisfaction score

    Time frame: From baseline to Day 364

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2016
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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