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An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy


Phase 3
20 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy


Inclusion Criteria:



- 20 years or older

- Has a histological confirmed prostate cancer

- Has a screening serum testosterone above 1.5 ng/mL

- Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2

- Has a life expectancy of at least 168 days

Exclusion Criteria:

- Current or previous hormone therapy

- Is currently treated with 5-α-reductase inhibitor

- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema

- Is considered to be a candidate for curative therapy, i.e radical prostatectomy or
radiotherapy

- Has had cancer within the last five years except prostate cancer and surgically
removed basal or squamous cell carcinoma of the skin.

- Has a clinically significant disorder (other than prostate cancer) or any other
condition , including alcohol or drug abuse, which may interfere with trial
participation or which may affect the conclusion of the trial as judged by the
investigator

- Has received an investigational drug within the last 28 days preceding Screening
Visit or longer if considered to possibly influence the outcome of the current trial

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Testosterone level

Outcome Time Frame:

Every month during 6 months of treatment

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Taiwan: Department of Health

Study ID:

FE200486 CS43

NCT ID:

NCT01220869

Start Date:

December 2010

Completion Date:

October 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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