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Hormones

Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0.

Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

degarelix

Clinical Development Support

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer

Response to treatment was defined as:

* Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
* No response (increase): Difference \> +10% of Baseline level

Response to treatment was defined as:

* Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
* No response (increase): Difference \> +10% of Baseline level.

Per protocol, the one month timeframe was only analyzed for cohort 2.

Response to treatment was defined as:

* Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
* No response (increase): Difference \> +10% of Baseline level.

Per protocol, the two month timeframe was only analyzed for cohort 2.

Participants who had no post-baseline serum testosterone level above castrate level which was \<=0.5 ng/mL.

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL

Counts of participants who had PSA progression during the study. PSA progression was defined as PSA \>+10% of baseline value.

The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

Ferring Pharmaceuticals

Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Degarelix - Cohort 1

Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Degarelix - Cohort 2

Total

Age Continuous

Sex: Female, Male

Not Hispanic or Latino

HIspanic or Latino

Race/Ethnicity, Customized

White

Other

Weight

Height

Localized

Locally advanced

Metastatic

Not classifiable

Stage of Prostate Cancer at Diagnosis

Stage of Prostate Cancer at Enrolment

7-10

The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a Gleason Score with a range of 2-10; 10=worst prognosis.

Gleason Score

Fully active

Restricted, but ambulatory

Ambulatory, unable to work

Capable of only limited selfcare

Completely disabled

Eastern Cooporative Oncology Group (ECOG) Performance Status

Response

No Response

Intent to treat population. Last observation carried forward.

Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.

Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.

Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

Participants at Testosterone Castrate Level Throughout the Study

Intent to treat population with a baseline and at least one scheduled post-baseline measurement.

Change From Baseline in Serum Levels of Testosterone at the Last Visit

Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit

Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit

Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit

Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.

Participants at Testosterone Level <=0.2 ng/mL Throughout the Study

Participants at Testosterone Level <=0.32 ng/mL Throughout the Study

Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study

Intent to treat population.

Analysis was not performed since no participants died during study.

Spots Global Cancer Trial Database for agonist treatment failure