A Trial of Degarelix in Patients With Prostate Cancer

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects who met the eligibility criteria were randomized to degarelix or goserelin acetate treatment in a 2:1-ratio. 859 subjects were randomized but 11 subjects did not receive any treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Participant Flow:   Overall Study

	Degarelix 240 mg/480 mg	Goserelin Acetate
STARTED	565 [1]	283 [2]
Full Analysis Set (FAS)	565 [3]	282 [4]
COMPLETED	455	239
NOT COMPLETED	110	44
Withdrawal by Subject	28	15
Lost to Follow-up	2	2
Physician Decision	5	2
Adverse Event	41	14
Protocol Violation	16	8
Miscellaneous reasons	18	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Total	Total of all reporting groups

Baseline Measures

	Degarelix 240 mg/480 mg	Goserelin Acetate	Total
Overall Participants Analyzed  [Units: Participants]	565	282	847
Age  [Units: Years] Mean (Standard Deviation)	71.9  (8.3)	71.1  (7.9)	71.6  (8.2)
Gender  [Units: Participants]
Female	0	0	0
Male	565	282	847
Race (NIH/OMB)  [Units: Participants]
American Indian or Alaska Native	45	25	70
Asian	4	1	5
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	41	16	57
White	475	239	714
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Median Baseline Serum Testosterone Levels (ng/mL)  [Units: ng/mL] Median (Full Range)	4.52   (0.56 to 14.5)	4.62   (0.07 to 13.2)	4.54   (0.07 to 14.5)
Median Baseline Serum Prostate-specific Antigen Levels (ng/mL)  [Units: ng/mL] Median (Full Range)	19.0   (0.26 to 8762)	19.1   (0.01 to 12961)	19.0   (0.01 to 12961)
Baseline Short Form-36 (SF-36) Total Scores [1]  [Units: Units on a scale] Mean (Standard Deviation)	49.7  (11.5)	50.2  (11.4)	49.9  (11.4)
[1] The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Baseline Total International Prostate Symptom Scores (IPSS) [1]  [Units: Units on a scale] Mean (Standard Deviation)	11.8  (7.93)	11.6  (8.02)	11.7  (7.96)
[1] IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of “0” corresponds to a response of “not at all” for the first six symptoms and “none” for nocturia, and a score of 5 corresponds to a response of “almost always” for the first six symptoms and “5 times or more” for nocturia.

1.  Primary:

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

2.  Primary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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 ]

6.  Secondary:

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 ]