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The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.


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

Thank you

Trial Information

The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.


Inclusion Criteria:



- Patients, aged 18 years or older, with a histologically proven prostate cancer of all
stages in whom endocrine treatment is indicated.

- Screening testosterone level above the lower limit of normal range, globally defined
as > 2.2 ng/mL.

- Screening PSA level of =2 ng/mL. ECOG score of =2.

- Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day
364.

Secondary endpoints:

- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day
364.

- Serum levels of testosterone, LH, FSH, and PSA over time.

- Time to PSA failure - defined as two consecutive increases of 50%, and at least 5
ng/mL, compared to nadir.

- Plasma levels of degarelix over time.

- Frequency and severity of adverse events.

- Clinically significant changes in laboratory safety parameters.

- Clinically significant changes in physical examinations, ECGs, vital signs, and body
weight.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.

Outcome Time Frame:

3-month

Safety Issue:

Yes

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS26

NCT ID:

NCT00728533

Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer requiring Androgen Ablation Therapy
  • Prostatic Neoplasms

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