The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Prostate Cancer
Intervention:	Drug: Degarelix

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred and fifty-nine participants were screened. One hundred and twenty-nine participants were randomised, two of these participants withdrew before receiving any treatment.

Reporting Groups

	Description
Degarelix 80/80 + 40	Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40	Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20	Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.

Participant Flow: Overall Study

	Degarelix 80/80 + 40	Degarelix 40/40 + 40	Degarelix 80 + 20
STARTED	43	46	40
Randomized	43	46	40
Intent-to-Treat Population	42^[1]	46	39^[2]
Per Protocol Population	38^[3]	44^[4]	38^[5]
COMPLETED	32	30	26
NOT COMPLETED	11	16	14
Adverse Event	0	5	3
Insufficient testosterone response	5	8	10
Withdrawal by Subject	1	0	0
Protocol Violation	1	0	1
Mistakenly withdrawn	0	1	0
Bad prostate-specific antigen response	3	2	0
not specified	1	0	0

[1]	One randomised participant withdrew at Day 1.
[2]	One randomised participant withdrew at Day 1.
[3]	One participant- baseline testosterone outside normal range. Three participants- prohibited drugs.
[4]	Two participants - prohibited drugs
[5]	One participant - baseline testosterone outside normal range.

Baseline Characteristics

Reporting Groups

	Description
Degarelix 80/80 + 40	Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40	Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20	Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.

Baseline Measures

	Degarelix 80/80 + 40	Degarelix 40/40 + 40	Degarelix 80 + 20	Total
Number of Participants [units: participants]	43	46	40	129
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	6	5	7	18
>=65 years	37	41	33	111
Age [units: years] Mean ± Standard Deviation	72.4 ± 6.6	73.7 ± 7.2	71.8 ± 7.1	72.7 ± 7.0
Gender [units: participants]
Female	0	0	0	0
Male	43	46	40	129
Race, Customized [units: participants]
White	42	43	37	122
Black	1	3	1	5
Oriental / Asian	0	0	0	0
Afro-carribean	0	0	1	1
Indian	0	0	1	1
Region of Enrollment [units: participants]
United Kingdom	43	46	40	129
Participant Counts by Gleason Score^[1] [units: participants]
unknown	1	1	1	3
2-4	3	4	2	9
5-6	11	7	11	29
7-10	28	34	26	88
Stage of Prostate Cancer^[2] [units: participants]
Localized	8	9	5	22
Locally advanced	21	21	18	60
Metastatic	11	14	17	42
Not classifiable	3	2	0	5
Body Mass Index^[3] [units: kilogram per square meter] Median ( Full Range )	26.2 ( 18.0 to 36.4 )	26.6 ( 17.4 to 40.9 )	25.2 ( 19.8 to 34.1 )	26.1 ( 17.4 to 40.9 )
Days Since Diagnosis of Prostate Cancer^[4] [units: days] Mean ± Standard Deviation	52.7 ± 116.0	153.8 ± 518.1	88.8 ± 370.0	99.9 ± 377.2
Serum Prostate-Specific Antigen level^[5] [units: nanogram/milliliter] Median ( Full Range )	50.3 ( 23.2 to 2580 )	64.6 ( 18.1 to 2380 )	82.9 ( 23.7 to 12500 )	61.1 ( 18.1 to 12500 )
Serum Testosterone level^[6] [units: nanogram/milliliter] Median ( Full Range )	3.7 ( 2.13 to 7.63 )	4.1 ( 1.21 to 7.84 )	4.8 ( 1.58 to 8.94 )	4.0 ( 1.21 to 8.94 )

[1]	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.
[2]	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.
[3]	Body mass index is a measure of body fat based on height and weight
[4]	The number of days passed since a diagnosis of prostate cancer was made for each participant.
[5]	Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a positive correlation to prostate cancer.
[6]	Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.

Outcome Measures

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1. Primary Outcome Measure: Number of Participants With Testosterone <0.5 Nanogram/Milliliter

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2. Secondary Outcome Measure: Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24

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3. Secondary Outcome Measure: Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24

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4. Secondary Outcome Measure: Number of Participants Who Met the Withdrawl Criteria for Prostate-Specific Antigen

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5. Secondary Outcome Measure: Number of Participants With Normal Prostate-Specific Antigen Levels During the Study

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6. Secondary Outcome Measure: The Number of Participants With Abnormal Liver Function Tests

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7. Secondary Outcome Measure: Percentage Change in Vital Signs and Body Weight

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Reported Adverse Events

Reporting Groups

	Description
Degarelix 80/80 + 40	Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40	Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20	Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.

Serious Adverse Events

	Degarelix 80/80 + 40	Degarelix 40/40 + 40	Degarelix 80 + 20
Total, serious adverse events
number of participants affected	3	8	6
Blood and lymphatic system disorders
Anaemia † number of participants at risk number of events number of participants affected	43 1 1	46 1 1	40 0 0
Cardiac disorders
Angina pectoris † number of participants at risk number of events number of participants affected	43 1 1	46 0 0	40 1 1
Myocardial infarction † number of participants at risk number of events number of participants affected	43 1 1	46 1 1	40 0 0
Cardiac failure congestive † number of participants at risk number of events number of participants affected	43 1 1	46 0 0	40 0 0
Gastrointestinal disorders
Nausea † number of participants at risk number of events number of participants affected	43 0 0	46 2 1	40 0 0
Rectal haemorrhage † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Vomiting † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
General disorders
Asthenia † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Catheter related complication † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Condition aggravated † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Hepatobiliary disorders
Hepatic function abnormal † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Immune system disorders
Hypersensitivity † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Infections and infestations
Lobar pneumonia † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Sepsis † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Injury, poisoning and procedural complications
Post procedural haemorrhage † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Musculoskeletal and connective tissue disorders
Arthralgia † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Nervous system disorders
Cerebral haemorrhage † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Cerebrovascular accident † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Syncope † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Psychiatric disorders
Depression † number of participants at risk number of events number of participants affected	43 1 1	46 0 0	40 1 1
Alcoholism † number of participants at risk number of events number of participants affected	43 1 1	46 0 0	40 0 0
Renal and urinary disorders
Bladder obstruction † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Calculus bladder † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Dysuria † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 1 1
Urine flow decreased † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 0 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea † number of participants at risk number of events number of participants affected	43 0 0	46 2 1	40 0 0

† Indicates events were collected by systematic assessment. All other events were spontaneously reported.

Frequency Threshold for Reporting Other Adverse Events: 5%

Other Adverse Events

	Degarelix 80/80 + 40	Degarelix 40/40 + 40	Degarelix 80 + 20
Total, other (not including serious) adverse events
number of participants affected	38	38	32
Gastrointestinal disorders
Diarrhoea † number of participants at risk number of events number of participants affected	43 9 6	46 2 2	40 4 2
Constipation † number of participants at risk number of events number of participants affected	43 3 3	46 1 1	40 1 1
Inguinal hernia † number of participants at risk number of events number of participants affected	43 1 1	46 1 1	40 2 2
Dyspepsia † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 2 2
Abdominal pain † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 2 2
General disorders
Fatigue † number of participants at risk number of events number of participants affected	43 2 2	46 5 4	40 0 0
Suprapubic pain † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 2 2
Infections and infestations
Nasopharyngitis † number of participants at risk number of events number of participants affected	43 6 5	46 7 7	40 5 5
Urinary tract infection † number of participants at risk number of events number of participants affected	43 5 3	46 1 1	40 2 2
Investigations
Weight increased † number of participants at risk number of events number of participants affected	43 0 0	46 0 0	40 2 2
Musculoskeletal and connective tissue disorders
Back pain † number of participants at risk number of events number of participants affected	43 3 3	46 3 3	40 2 2
Arthralgia † number of participants at risk number of events number of participants affected	43 0 0	46 3 3	40 0 0
Nervous system disorders
Headache † number of participants at risk number of events number of participants affected	43 5 4	46 2 2	40 4 3
Lethargy † number of participants at risk number of events number of participants affected	43 2 2	46 4 3	40 1 1
Renal and urinary disorders
Dysuria † number of participants at risk number of events number of participants affected	43 4 3	46 0 0	40 4 2
Pollakiuria † number of participants at risk number of events number of participants affected	43 0 0	46 1 1	40 2 2
Reproductive system and breast disorders
Testicular atrophy † number of participants at risk number of events number of participants affected	43 3 3	46 2 2	40 4 4
Respiratory, thoracic and mediastinal disorders
Cough † number of participants at risk number of events number of participants affected	43 2 2	46 2 2	40 2 2
Skin and subcutaneous tissue disorders
Hyperhidrosis † number of participants at risk number of events number of participants affected	43 3 3	46 3 3	40 1 1
Skin reaction † number of participants at risk number of events number of participants affected	43 3 3	46 0 0	40 0 0
Vascular disorders
Hot flush † number of participants at risk number of events number of participants affected	43 22 21	46 21 21	40 25 22
Flushing † number of participants at risk number of events number of participants affected	43 4 4	46 6 6	40 2 2
Hypertension † number of participants at risk number of events number of participants affected	43 3 3	46 2 2	40 1 1

† Indicates events were collected by systematic assessment. All other events were spontaneously reported.

More Information

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
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Results Point of Contact:

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

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Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS02
Study First Received:	January 7, 2009
Results First Received:	January 22, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00819247 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee