A Trial of Degarelix in Patients With Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00946920
• Date of registration: 03/07/2009
• Prospective Registration: No
• Primary sponsor: Ferring Pharmaceuticals
• Public title: A Trial of Degarelix in Patients With Prostate Cancer
• Scientific title: An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
• Date of first enrolment: June 2009
• Target sample size: 859
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00946920
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Russian Federation, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older.

- Has a histological confirmed prostate cancer Gleason graded).

- Has a screening testosterone above 2.2 ng/mL.

- Rising prostate-specific antigen (PSA).

- Has Eastern Cooperative Oncology Group (ECOG) score of = 2.

- Has a life expectancy of at least one year.

Exclusion Criteria:

- Current or previous hormone therapy.

- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks,
respectively, prior to screening.

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

- Has a heart insufficiency.

- Has a previous history or presence of another malignancy, other than prostate cancer
or treated squamous/basal cell carcinoma of the skin, within the last five years.

- Has a clinically significant medical condition (other than prostate cancer) including,
but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac,
neurological, or psychiatric disease and alcohol or drug abuse or any other condition
which may affect the patient's health or the outcome of the trial as judged by the
Investigator.

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

- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Degarelix

Drug: Goserelin acetate

Primary Outcome(s)

Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL) With Degarelix [Time Frame: From Day 28 to Day 364]

Difference in Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL) Between Degarelix and Goserelin [Time Frame: Day 3 to Day 364]

Secondary Outcome(s)

Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline [Time Frame: At baseline, 10 months and 13 months]

Serum Levels of Testosterone Over Time [Time Frame: Baseline and after 1, 2, 3, 6 and 13 months]

Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time [Time Frame: Baseline and after 1, 2, 3, 6 and 13 months]

Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline [Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months]

Secondary ID(s)

2008-005276-27

FE200486 CS35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00946920