Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

This study has been completed.

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00268892

First received: December 21, 2005

Last updated: December 8, 2010

Last verified: December 2010

History of Changes

Results First Received: November 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Degarelix

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.

Reporting Groups

	Description
Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Participant Flow: Overall Study

	Degarelix 240/240@40(1-3-6-9)	Degarelix 240/240@60(1-3-6-9)	Degarelix 240/240@60(1-4-7-10)
STARTED	90	95	93
Switched to Higher Dose	59	68	76
COMPLETED	51	53	54
NOT COMPLETED	39	42	39
Adverse Event	14	17	20
Lack of Efficacy	1	3	0
Withdrawal by Subject	14	15	13
Physician Decision	0	1	0
Lost to Follow-up	5	2	4
Protocol Violation	0	1	0
Disease Progression	1	1	0
Trial Site Closed	4	2	2

Baseline Characteristics

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Reporting Groups

	Description
Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Total	Total of all reporting groups

Baseline Measures

	Degarelix 240/240@40(1-3-6-9)	Degarelix 240/240@60(1-3-6-9)	Degarelix 240/240@60(1-4-7-10)	Total
Number of Participants [units: participants]	90	95	93	278
Age ^[1] [units: years] Mean ± Standard Deviation	72.7 ± 6.55	73.3 ± 7.00	71.8 ± 7.05	72.6 ± 6.88
Gender ^[1] [units: participants]
Female	0	0	0	0
Male	90	95	93	278
Race (NIH/OMB) ^[1] [units: participants]
American Indian or Alaska Native	0	0	1	1
Asian	0	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	5	3	11
White	87	89	88	264
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Body Weight ^[1] [units: kilogram] Mean ± Standard Deviation	76.7 ± 13.0	76.9 ± 12.2	76.5 ± 12.8	76.7 ± 12.6
Body Mass Index ^[1] [units: kilogram per square meter] Mean ± Standard Deviation	25.4 ± 4.14	25.8 ± 3.93	25.8 ± 4.16	25.7 ± 4.07
Curative Intent ^[2] [units: participants]
Yes	10	12	7	29
No	80	83	86	249
Gleason Score ^[3] [units: participants]
2-4	13	6	13	32
5-6	33	30	34	97
7-10	44	58	46	148
Stage of Prostate Cancer ^[4] [units: participants]
Localized	34	37	36	107
Locally Advanced	26	26	28	80
Metastatic	16	19	20	55
Not Classifiable	14	13	9	36
Time since Prostate Cancer Diagnosis ^[1] [units: days] Mean ± Standard Deviation	469 ± 1079	347 ± 824	255 ± 583	356 ± 852

[1]	Safety analysis set.
[2]	Safety analysis set. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
[3]	Safety analysis set. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. A Gleason Score was missing for one participant in the Degarelix 240/240@60(1-3-6-9) group.
[4]	Safety analysis set. Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.

Outcome Measures

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1. Primary:

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline and up to 4.5 years ]

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2. Primary:

Liver Function Tests [ Time Frame: 4.5 years ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
e-mail: DK0-Disclosure@ferring.com

No publications provided

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00268892 History of Changes
Other Study ID Numbers:	FE200486 CS15A
Study First Received:	December 21, 2005
Results First Received:	November 17, 2010
Last Updated:	December 8, 2010
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) Netherlands: Independent Ethics Committee Belgium: Federal Agency for Medicines and Health Products, FAMHP Belgium: Institutional Review Board France: Ministry of Health France: National Consultative Ethics Committee for Health and Life Sciences Romania: Ministry of Public Health Romania: National Authority for Scientific Research Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee Germany: Ministry of Health Germany: Ethics Commission Finland: Ethics Committee Finland: Finnish Medicines Agency Serbia and Montenegro: Agency for Drugs and Medicinal Devices Serbia: Ethics Committee

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