A Trial of Degarelix in Patients With Prostate Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00946920

First received: July 3, 2009

Last updated: May 2, 2014

Last verified: May 2014

History of Changes

Results First Received: February 14, 2014

Study Type:	Interventional
Study Design:	Allocation: 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
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
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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

^[1]	Received at least one dose of degarelix.
^[2]	Received at least one dose of goserelin acetate.
^[3]	Received at least one dose of degarelix and had at least one post-dosing efficacy assessment.
^[4]	Received at least one dose of goserelin and had at least one post-dosing efficacy assessment.

Baseline Characteristics

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Outcome Measures

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1. Primary:

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

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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 ]

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3. Secondary:

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

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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 ]

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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 ]

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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 ]

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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:	NCT00946920 History of Changes
Other Study ID Numbers:	FE200486 CS35 2008-005276-27 ( EudraCT Number )
Study First Received:	July 3, 2009
Results First Received:	February 14, 2014
Last Updated:	May 2, 2014

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