Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

This study has been terminated.

( Poor recruitment due to rare targeted population )

Study NCT00831233 Information provided by Ferring Pharmaceuticals

First Received on January 27, 2009. Last Updated on July 28, 2011 History of Changes

Results First Received: June 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: Degarelix Drug: Goserelin Drug: Bicalutamide

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
The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.

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/80 mg	Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
Goserelin (3.6 mg) + Bicalutamide (50 mg)	Goserelin (3.6 mg) + bicalutamide (50 mg)

Participant Flow: Overall Study

	Degarelix 240 mg/80 mg	Goserelin (3.6 mg) + Bicalutamide (50 mg)
STARTED	29 ^[1]	13 ^[2]
Full Analysis Set (FAS)	27 ^[3]	13
Per Protocol (PP) Analysis Set	26	11
COMPLETED	26	12
NOT COMPLETED	3	1
Adverse Event	0	1
Protocol Violation	1	0
Selection Criteria Not Met	2	0

[1]	Intention-to-treat (ITT) population.
[2]	ITT population.
[3]	2 participants were randomised but never treated.

Baseline Characteristics

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Reporting Groups

	Description
Degarelix 240 mg/80 mg	Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
Goserelin (3.6 mg) + Bicalutamide (50 mg)	Goserelin (3.6 mg) + bicalutamide (50 mg)

Baseline Measures

	Degarelix 240 mg/80 mg	Goserelin (3.6 mg) + Bicalutamide (50 mg)	Total
Number of Participants [units: participants]	27	13	40
Age ^[1] [units: years] Mean ± Standard Deviation	69.9 ± 8.68	71.0 ± 8.39	70.3 ± 8.49
Gender ^[2] [units: participants]
Female	0	0	0
Male	27	13	40
Race (NIH/OMB) ^[2] [units: participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	27	12	39
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment ^[2] [units: participants]
Spain	4	4	8
Germany	13	7	20
United Kingdom	10	2	12
Body weight ^[2] [units: kilogram] Mean ± Standard Deviation	81.4 ± 14.0	78.2 ± 8.5	80.3 ± 12.5
Body mass index ^[2] [units: kilogram per square meter] Mean ± Standard Deviation	26.7 ± 4.06	26.8 ± 3.75	26.7 ± 3.91
Gleason Score ^[3] [units: participants]
2-4	0	0	0
5-6	2	0	2
7-10	25	13	38
Stage of Prostate Cancer ^[4] [units: participants]
Localized	4	0	4
Locally Advanced	4	1	5
Metastatic	10	4	14
Not Classifiable	9	8	17

[1]	Full Analysis Set (FAS).
[2]	FAS.
[3]	FAS. 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.
[4]	FAS. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale 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. The majority of participants did not have their prostate cancer classified for the complete TNM scale (17 participants) or were known for having metastatic prostate cancer (14 participants).

Outcome Measures

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1. Primary:

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: After treatment of 12 weeks compared to Baseline ]

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2. Secondary:

Change From Baseline in Total IPSS at Weeks 4 and 8 [ Time Frame: After treatment of 4 and 8 weeks compared to Baseline ]

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3. Secondary:

Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ]

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4. Secondary:

Change From Baseline in Residual Volume (Vresidual) at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ]

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5. Secondary:

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 [ Time Frame: After 12 weeks treatment compared to Baseline ]

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6. Secondary:

Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ]

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7. Secondary:

Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ]

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8. Secondary:

Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ]

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9. Secondary:

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline to 12 weeks of treatment ]

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10. Secondary:

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Baseline to 12 weeks of treatment ]

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

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
Early termination leading to small numbers of subjects analyzed.

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:	NCT00831233 History of Changes
Other Study ID Numbers:	FE200486 CS28, 2008-004338-26
Study First Received:	January 27, 2009
Results First Received:	June 14, 2011
Last Updated:	July 28, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines