A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00116779
• Collaborator: (none)
• Enrollment: 127
• Locations: 35
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Degarelix	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Degarelix 60mg Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Drug: Degarelix; Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.; Other Names: FE200486
Experimental: Degarelix 80mg Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.	Drug: Degarelix; Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.; Other Names: FE200486

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 [Day 28 to Day 364]

   Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364

2. Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28 [Day 28 - Day 364]

   Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.

Secondary Outcome Measures

1. Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3. [Day 3]

   Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

2. Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen [Day 0 (post dose) to Day 364]

   Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

3. Days to Prostate-Specific Antigen Progression [Day 0 (post dose) to Day 364]

   Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

4. Median Di-Hydrotestosterone Levels At Various Study Timepoints [Baseline, Days 1, 3, 7, 14]

   Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

5. Median Prostate-Specific Antigen Values at Various Study Timepoints [Baseline, Days 3, 14, 28, 84, 364]

   Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

6. Median Luteinizing Hormone Levels at Various Study Timeframes [Baseline, Days 1, 3, 7, 14]

   Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

7. Median Testosterone Levels at Various Days During the Study [Baseline, Days 1,3,7,14,364]

   Testosterone levels at baseline and days 1, 3, 7, 14 and 364

8. Number of Participants With Abnormal Alanine Aminotransferase Values [Day 1 through day 364]

   Participants whose alanine aminotransferase values were at levels above the normal range.

9. Number of Participants With Abnormal Aspartate Aminotransferase Values [Day 1 - 364]

   Participants with aspartate aminotransferase values that were above the normal range.

10. Number of Participants With Abnormal Total Bilirubin Values [Day 1 - 364]

    Participants with abnormal total bilirubin values

11. Participants With Markedly Abnormal Changes in Vital Signs or Body Weight [Day 364]

    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study.

• Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).

• Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.

• Male patient aged 18 years or over.

• Has a baseline testosterone above the lower limit of normal range.

• Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.

• Has a PSA value of greater than or equal to 2ng/mL.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study.

• Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.

• Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.

• Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.

• Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.

• Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).

• Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.

• Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.

• Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.

• Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.

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

• Has a mental incapacity or language barriers precluding adequate understanding or cooperation.

• Has received an investigational drug within the last 12 weeks preceding Screening Visit.

• Has previously participated in any degarelix study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Centers of Alabama	Homewood	Alabama	United States	35209
2	Alaska Clinical Research Center, LLC	Anchorage	Alaska	United States	99508
3	Advanced Urology Medical Center	Anaheim	California	United States	92801
4	South Orange County Medical Research Cnter	Laguna Woods,	California	United States	92653
5	Pacific Clinical Research	Santa Monica	California	United States	90404
6	West Coast Clinical Research	Tarzana	California	United States	91356
7	Western Clinical Research	Torrance	California	United States	90505
8	Urology Associate PC	Denver	Colorado	United States	80210
9	South Florida Medical Research	Aventura	Florida	United States	33180
10	SW Florida Urological Associates	Fort Myers	Florida	United States	33907
11	Florida Foundation for Healthcare Research	Ocala	Florida	United States	34474
12	RMD Clinical Reseach Institution LLC	Melrose Park	Illinois	United States	60160
13	Northeast Indiana Research, LLC	Fort Wayne	Indiana	United States	46825
14	Regional Urology	Shreveport	Louisiana	United States	71106
15	Nevada Urology Associates	Reno	Nevada	United States	89511
16	Lawrenceville Urology	Lawrenceville	New Jersey	United States	08648
17	Hudson Valley Urology PC	Poughkeepsie	New York	United States	12601
18	The Urology Center	Greensboro	North Carolina	United States	27401
19	State College Urologic Association	State College	Pennsylvania	United States	16801
20	Univeristy Urological Research Institute	Providence	Rhode Island	United States	02904
21	Urology San Antonio Research	San Antonio	Texas	United States	78229
22	Scott & White Memorial Hospital	Temple	Texas	United States	76508
23	University of Vermont, Dept of Surgery	South Burlington	Vermont	United States	05403
24	Virginia Urology Center	Richmond	Virginia	United States	23235
25	Office of Jeffrey Frankel	Seattle	Washington	United States	98166
26	Wyoming Research Foundation	Cheyenne	Wyoming	United States	82001
27	Southern Interior Medical Research Corporation	Kelowna	British Columbia	Canada	V1Y2H4
28	Dr. Cal Abdreau Research	Surrey	British Columbia	Canada	V3V1N1
29	Can-Med Clinical Research, Inc.	Victoria	British Columbia	Canada	V8T5G1
30	Dr. Gary Steinhoff Clinical Research	Victoria	British Columbia	Canada	V8V3N1
31	Valley Professional Center	Kentville	Nova Scotia	Canada	B4N4K9
32	The Male and Female Health and Research Centers	Barrie	Ontario	Canada	L4M7G1
33	Brantford Urology Research	Brantford	Ontario	Canada	N3R4N3
34	Burlington Professional Care	Burlington	Ontario	Canada	L7N3V2
35	The Female/Male Health Centres	Oakville	Ontario	Canada	L6H3P1

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00116779
• Other Study ID Numbers: FE200486 CS14
• First Posted: Jul 1, 2005
• Last Update Posted: Dec 19, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Ferring Pharmaceuticals: Prostate Cancer; Androgen ablation therapy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	One hundred and seventy-six patients were screened to identify the one hundred and twenty-seven patients who were eligible for randomization.

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Period Title: Overall Study
STARTED	63	64
COMPLETED	42	45
NOT COMPLETED	21	19

Baseline Characteristics

Arm/Group Title	Degarelix 60mg	Degarelix 80mg	Total
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.	Total of all reporting groups
Overall Participants	63	64	127
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 14.3%	9 14.1%	18 14.2%
>=65 years	54 85.7%	55 85.9%	109 85.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.8 (8.73)	74.9 (9.55)	74.9 (9.12)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	63 100%	64 100%	127 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.6%	1 1.6%	2 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	14 22.2%	4 6.3%	18 14.2%
White	48 76.2%	59 92.2%	107 84.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Curative Intent (participants) [Number]
No	41 65.1%	40 62.5%	81 63.8%
Yes	22 34.9%	24 37.5%	46 36.2%
Participant Counts by Gleason Score (participants) [Number]
2-4	3 4.8%	3 4.7%	6 4.7%
5-6	19 30.2%	22 34.4%	41 32.3%
7-10	41 65.1%	39 60.9%	80 63%
The Number of Participants at Each Stage of Prostate Cancer (participants) [Number]
Localized	31 49.2%	23 35.9%	54 42.5%
Locally advanced	5 7.9%	9 14.1%	14 11%
Metastatic	15 23.8%	9 14.1%	24 18.9%
Not classifiable	12 19%	23 35.9%	35 27.6%
Body Mass Index (kilogram per square meter) [Mean (Full Range) ]
Mean (Full Range) [kilogram per square meter]	27.3 (4.1)	26.7 (3.98)	27 (4.03)
Days Since Diagnosis of Prostate Cancer (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	1213 (1597)	1256 (1550)	1234 (1568)
Serum Prostate-Specific Antigen (nanograms/milliliter) [Median (Full Range) ]
Median (Full Range) [nanograms/milliliter]	12.7	13.7	13.4
Serum Testosterone level (nanograms/milliliter) [Median (Full Range) ]
Median (Full Range) [nanograms/milliliter]	4.1	4.23	4.13
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	83 (14.6)	81.2 (12.7)	82.1 (13.7)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
Description	Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364
Time Frame	Day 28 to Day 364

Outcome Measure Data

Analysis Population Description

ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	49	53
Number [participants]	42 66.7%	41 64.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	86
	Confidence Interval	() 95%; 73 to 94
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 80mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	77
	Confidence Interval	() 95%; 64 to 88
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

2. Secondary Outcome

Title	Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
Description	Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Number [participants]	54 85.7%	56 87.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	90
	Confidence Interval	() 95%; 79 to 96
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 80mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	89
	Confidence Interval	() 95%; 78 to 95
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg, Degarelix 80mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8413
	Comments
	Method	Chi-squared
	Comments

3. Primary Outcome

Title	Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
Description	Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.
Time Frame	Day 28 - Day 364

Outcome Measure Data

Analysis Population Description

ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	45	42
Number [participants]	42 66.7%	41 64.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	93
	Confidence Interval	() 95%; 82 to 99
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 80mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	98
	Confidence Interval	() 95%; 87 to 100
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was calculated by Clopper-Pearson method.

4. Secondary Outcome

Title	Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
Description	Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.
Time Frame	Day 0 (post dose) to Day 364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
50 percent reduction (n=59, 59)	14	14
90 percent reduction (n=45, 48)	56	56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg, Degarelix 80mg
	Comments	Time to 50% reduction
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.904
	Comments
	Method	Log Rank
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 60mg, Degarelix 80mg
	Comments	Days to 90% reduction
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.778
	Comments
	Method	Log Rank
	Comments

5. Secondary Outcome

Title	Days to Prostate-Specific Antigen Progression
Description	Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.
Time Frame	Day 0 (post dose) to Day 364

Outcome Measure Data

Analysis Population Description

ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Median (Full Range) [days]	196	154

6. Secondary Outcome

Title	Median Di-Hydrotestosterone Levels At Various Study Timepoints
Description	Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14
Time Frame	Baseline, Days 1, 3, 7, 14

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Baseline (n=63, 64)	360	350
Day 1 (n=62, 62)	110	120
Day 3 (n=58, 63)	56.5	57
Day 7 (n=58, 63)	45.5	52
Day 14 (n=61, 61)	37	40

7. Secondary Outcome

Title	Median Prostate-Specific Antigen Values at Various Study Timepoints
Description	Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.
Time Frame	Baseline, Days 3, 14, 28, 84, 364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Baseline (n=63, 64)	12.7	13.7
Day 3 (n=60, 64)	11.4	12.2
Day 14 (n=61, 63)	6.4	6.8
Day 28 (n=61, 63)	2.9	3.6
Day 84 (n=57, 54)	0.8	0.7
Day 364 (n=42, 43)	0.4	0.2

8. Secondary Outcome

Title	Median Luteinizing Hormone Levels at Various Study Timeframes
Description	Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.
Time Frame	Baseline, Days 1, 3, 7, 14

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Baseline (n=63, 64)	5.28	5.33
Day 1 (n=58, 61)	0.915	0.87
Day 3 (n=59, 60)	0.43	0.425
Day 7 (n=60, 61)	0.41	0.6
Day 14 (n=61, 62)	0.2	0.37

9. Secondary Outcome

Title	Median Testosterone Levels at Various Days During the Study
Description	Testosterone levels at baseline and days 1, 3, 7, 14 and 364
Time Frame	Baseline, Days 1,3,7,14,364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Baseline (n=63, 64)	4.1	4.23
Day 1 (n=61, 63)	0.56	0.71
Day 3 (n=60, 63)	0.26	0.31
Day 7 (n=60, 64)	0.18	0.24
Day 14 (n=61, 63)	0.11	0.14
Day 364 (n=42, 43)	0.07	0.07

10. Secondary Outcome

Title	Number of Participants With Abnormal Alanine Aminotransferase Values
Description	Participants whose alanine aminotransferase values were at levels above the normal range.
Time Frame	Day 1 through day 364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	62	64
> upper limit and 3 times upper limit	10 15.9%	21 32.8%
Total abnormal (> upper limit)	10 15.9%	21 32.8%
Total normal (<=upper limit)	52 82.5%	43 67.2%

11. Secondary Outcome

Title	Number of Participants With Abnormal Aspartate Aminotransferase Values
Description	Participants with aspartate aminotransferase values that were above the normal range.
Time Frame	Day 1 - 364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	62	64
> 3 times upper limit - 5 times upper limit	0 0%	1 1.6%
> upper limit - 3 times upper limit	6 9.5%	5 7.8%
Total Abnormal (> upper limit)	6 9.5%	6 9.4%
Total Normal (<= upper limit)	56 88.9%	58 90.6%

12. Secondary Outcome

Title	Number of Participants With Abnormal Total Bilirubin Values
Description	Participants with abnormal total bilirubin values
Time Frame	Day 1 - 364

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	62	64
>2 times upper limit	0 0%	1 1.6%
>1.5 times upper limit	2 3.2%	4 6.3%
> upper limit - 1.5 times upper limit	12 19%	9 14.1%
Total abnormal (> upper limit)	14 22.2%	14 21.9%
Total normal (<=upper limit)	48 76.2%	50 78.1%

13. Secondary Outcome

Title	Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Description	Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.
Time Frame	Day 364

Outcome Measure Data

Analysis Population Description

ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61

Arm/Group Title	Degarelix 60mg	Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Measure Participants	63	64
Diastolic blood pressure <= 50 and decrease >= 15	7 11.1%	5 7.8%
Diastolic blood pressure >= 105 and increase >= 15	1 1.6%	2 3.1%
Pulse <=50 and decrease of >=15	2 3.2%	5 7.8%
Pulse >=120 and increase of >=15	0 0%	0 0%
Systolic blood pressure <=90 and decrease >=20	5 7.9%	5 7.8%
Systolic blood pressure >=180 and increase >=20	6 9.5%	7 10.9%
Weight decrease of >=7 percent	2 3.2%	3 4.7%
Weight increase of >= 7 percent	7 11.1%	4 6.3%

Adverse Events

Arm/Group Title	Degarelix 60mg		Degarelix 80mg
Arm/Group Description	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.		Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
All Cause Mortality
	Degarelix 60mg		Degarelix 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Degarelix 60mg		Degarelix 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/ (NaN)		6/ (NaN)
Cardiac disorders
Myocardial infarction	1/63 (1.6%)	1	1/64 (1.6%)	1
Acute coronary syndrome	1/63 (1.6%)	1	0/64 (0%)	0
Acute myocardial infarction	0/63 (0%)	0	1/64 (1.6%)	1
Coronary artery disease	0/63 (0%)	0	1/64 (1.6%)	1
Gastrointestinal disorders
Constipation	1/63 (1.6%)	1	0/64 (0%)	0
Inguinal hernia, obstructive	0/63 (0%)	0	1/64 (1.6%)	1
General disorders
Injection site urticaria	1/63 (1.6%)	1	0/64 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/63 (0%)	0	1/64 (1.6%)	1
Infections and infestations
Pneumonia	1/63 (1.6%)	1	1/64 (1.6%)	1
Orchitis	1/63 (1.6%)	1	0/64 (0%)	0
Perirectal abscess	1/63 (1.6%)	1	0/64 (0%)	0
Pseudomembranous colitis	1/63 (1.6%)	1	0/64 (0%)	0
Injury, poisoning and procedural complications
Gastroenteritis radiation	1/63 (1.6%)	1	0/64 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/63 (1.6%)	1	0/64 (0%)	0
Nervous system disorders
Grand mal convulsion	1/63 (1.6%)	1	0/64 (0%)	0
Transient ischaemic attack	1/63 (1.6%)	1	0/64 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/63 (0%)	0	1/64 (1.6%)	2
Pulmonary embolism	1/63 (1.6%)	1	0/64 (0%)	0
Vascular disorders
Deep vein thrombosis	1/63 (1.6%)	1	0/64 (0%)	0
Other (Not Including Serious) Adverse Events
	Degarelix 60mg		Degarelix 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/ (NaN)		52/ (NaN)
Blood and lymphatic system disorders
Anaemia	3/63 (4.8%)	3	2/64 (3.1%)	2
Gastrointestinal disorders
Constipation	4/63 (6.3%)	4	4/64 (6.3%)	4
Diarrhoea	3/63 (4.8%)	3	2/64 (3.1%)	2
Nausea	3/63 (4.8%)	4	2/64 (3.1%)	2
General disorders
Fatigue	10/63 (15.9%)	12	15/64 (23.4%)	18
Injection site pain	4/63 (6.3%)	5	5/64 (7.8%)	9
Asthenia	2/63 (3.2%)	2	4/64 (6.3%)	5
Infections and infestations
Nasopharyngitis	7/63 (11.1%)	10	7/64 (10.9%)	7
Upper respiratory tract infection	1/63 (1.6%)	1	5/64 (7.8%)	6
Urinary tract infection	3/63 (4.8%)	4	2/64 (3.1%)	3
Lower respiratory tract infection	1/63 (1.6%)	1	3/64 (4.7%)	3
Injury, poisoning and procedural complications
Arthropod sting	3/63 (4.8%)	3	0/64 (0%)	0
Investigations
Weight increased	4/63 (6.3%)	4	4/64 (6.3%)	4
Gamma-glutamyltransferase increased	1/63 (1.6%)	2	3/64 (4.7%)	3
Musculoskeletal and connective tissue disorders
Arthralgia	3/63 (4.8%)	4	4/64 (6.3%)	4
Back pain	2/63 (3.2%)	2	5/64 (7.8%)	5
Musculoskeletal pain	0/63 (0%)	0	3/64 (4.7%)	4
Nervous system disorders
Dizziness	7/63 (11.1%)	11	6/64 (9.4%)	7
Psychiatric disorders
Insomnia	2/63 (3.2%)	2	5/64 (7.8%)	6
Anxiety	3/63 (4.8%)	3	1/64 (1.6%)	2
Renal and urinary disorders
Nocturia	1/63 (1.6%)	1	7/64 (10.9%)	7
Dysuria	3/63 (4.8%)	3	3/64 (4.7%)	4
Micturition urgency	1/63 (1.6%)	1	4/64 (6.3%)	5
Pollakiuria	4/63 (6.3%)	4	1/64 (1.6%)	1
Reproductive system and breast disorders
Erectile dysfunction	4/63 (6.3%)	4	6/64 (9.4%)	6
Gynaecomastia	3/63 (4.8%)	3	3/64 (4.7%)	4
Skin and subcutaneous tissue disorders
Rash	3/63 (4.8%)	4	3/64 (4.7%)	3
Vascular disorders
Hot flush	24/63 (38.1%)	26	31/64 (48.4%)	37
Hypertension	4/63 (6.3%)	4	4/64 (6.3%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of ublication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.