A Degarelix Trial in Patients With Prostate Cancer

This study has been terminated.

(Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.)

Sponsor:

Information provided by (Responsible Party):

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01242748

First received: November 16, 2010

Last updated: May 13, 2015

Last verified: May 2015

History of Changes

Results First Received: February 26, 2015

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: Degarelix Drug: Goserelin acetate

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
All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

Reporting Groups

Description

Degarelix 240 mg/480 mg

Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.

Goserelin Acetate

Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.

Participant Flow: Overall Study

	Degarelix 240 mg/480 mg	Goserelin Acetate
STARTED	194 ^[1]	94
CS35/CS35A Safety Analysis Set	565 ^[2]	283
CS35/CS35A Full Analysis Set (FAS)	565 ^[3]	282
COMPLETED	156 ^[4]	80
NOT COMPLETED	38	14
Adverse Event	10	5
Lost to Follow-up	6	2
Physician Decision	3	2
Protocol Violation	1	0
Withdrawal by Subject	10	2
Miscellaneous reasons	8	3

^[1]	Enrolled in CS35A, CS35A Full Analysis Set.
^[2]	Received at least 1 dose of trial drug during the main CS35 trial.
^[3]	Received at least 1 dose of trial drug during CS35+had at least 1 efficacy assessment after dosing.
^[4]	These participants were ongoing when the trial was closed by the Sponsor.

Baseline Characteristics

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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.
CS35A Full Analysis Set

Reporting Groups

	Description
Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Total	Total of all reporting groups

Baseline Measures

	Degarelix 240 mg/480 mg	Goserelin Acetate	Total
Overall Participants Analyzed [Units: Participants]	194	94	288

Age [Units: Years] Mean (Standard Deviation)	73.1 (8.4)	71.3 (7.0)	72.5 (8.0)

Gender [Units: Participants]
Female	0	0	0
Male	194	94	288

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	34	21	55
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	5	10
White	154	68	222
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Median Baseline Serum Testosterone Levels [Units: Nanogram per milliliter (ng/mL)] Median (Full Range)	4.41 (0.68 to 13.3)	4.65 (1.55 to 13.2)	4.52 (0.68 to 13.3)

Median Baseline Serum Prostate-specific Antigen Levels [Units: ng/mL] Median (Full Range)	20.6 (0.4 to 8762)	16.6 (1.49 to 12961)	18.7 (0.4 to 12961)

Outcome Measures

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1. Primary:

Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years’ Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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2. Secondary:

Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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3. Secondary:

Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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4. Secondary:

Hazard Ratio of Testosterone Escape Rates During 3 Years’ Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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5. Secondary:

Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years’ Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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6. Secondary:

Hazard Ratio of Mortality Rates During 3 Years’ Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]

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7. Secondary:

Serum Levels of Testosterone During 3 Years’ Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ]

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8. Secondary:

Serum Levels of Prostate-specific Antigen (PSA) During 3 Years’ Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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. Additional time may be required to allow Ferring to seek patent protection of the invention.

Results Point of Contact:

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

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01242748 History of Changes
Other Study ID Numbers:	FE200486 CS35A 2010-021434-55 ( EudraCT Number )
Study First Received:	November 16, 2010
Results First Received:	February 26, 2015
Last Updated:	May 13, 2015

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