Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

Detailed Description
-----------------
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Official Title
-----------------
An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained before any trial related procedures Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy ECOG score to be equal to or above 2 Testosterone level within age-specific normal range PSA value equal to or above 2 ng/ml Life expectancy of at least 6 months Exclusion Criteria: Previous or current hormonal treatment of prostate cancer Recent or current treatment with any drugs modifying the testosterone level Candidate for curative treatment such as prostatectomy or radiotherapy History of severe asthma, anaphylactic reactions or Quincke's Oedema Hypersensitivity towards any component of FE200486 Cancer disease within the last ten years except for prostate cancer and some skin cancers Signs of liver impairment shown as elevated serum ALT or serum bilirubin Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator Mental incapacity or language barrier Having received an investigational product within the last 12 weeks preceding the trial Previous participation in this trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix 120 mg (20 mg/mL)<br>Degarelix 120 mg (20 mg/mL) | Drug: Degarelix<br>* Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 120 mg (40 mg/mL)<br>Degarelix 120 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 160 mg (40 mg/mL)<br>Degarelix 160 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 200 mg (40 mg/mL)<br>Degarelix 200 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 200 mg (60 mg/mL)<br>Degarelix 200 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 240 mg (40 mg/mL)<br>Degarelix 240 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 240 mg (60 mg/mL)<br>Degarelix 240 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|
| Experimental: Degarelix 320 mg (60 mg/mL)<br>Degarelix 320 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection<br>* Other names: FE200486;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Dosing Until Testosterone Levels >0.5 ng/mL | Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days. | Two - six months | 
| Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days. | 3 months | 
| Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. | 3 months | 
| Time to 50% Reduction in Prostate-specific Antigen Levels | The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached. | 3 months | 
| Time to 90% Reduction in Prostate-specific Antigen Levels | The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached. | 3 months | 
| Evaluation of Liver Function Tests | The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | 3 months | 
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline. | 3 months |