Degarelix as Second-Line Hormonal Treatment After Prostat... | NCT00738673

ID	Type	Description	Link
2008-000585-22	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Degarelix	Experimental	Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.	Drug: degarelix

Name	Type	Description	Arm Group Labels	Other Names
degarelix	Drug	Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).	Degarelix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline	Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level	Day 0 (baseline), 3 months

Secondary Outcomes

Measure	Description	Time Frame
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline	Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.	Day 0 (baseline), 1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has given written informed consent before any trial-related activity is performed.
Patient is 18 years or older.
Histologically confirmed prostate cancer.
Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Estimated life expectancy at least 12 months.

Exclusion Criteria:

Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
Known hypersensitivity towards any component of the investigational medical product.
History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Known or suspected clinically significant liver and/or biliary disease.
Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
Previous participation in any degarelix trial.

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Urologische Praxis		Bautzen			Germany
Urologische Klinik

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
FG001	Degarelix - Cohort 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
BG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00024 BG00112 BG00236

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00072.7± 9.11 BG00176.5± 4.68 BG00273.9± 8.08

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Not Hispanic or Latino

Title	Measurements
	BG00024 BG00112 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00024 BG00112 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00090.5± 17.3 BG00187.6± 11.0 BG002

Height

Mean

Standard Deviation

meters

Title

Denominators

Categories

Title	Measurements
	BG0001.74± 0.06 BG0011.72± 0.05 BG002

Stage of Prostate Cancer at Diagnosis

Number

participants

Title

Denominators

Categories

Localized

Title	Measurements
	BG0004 BG0014 BG002

Stage of Prostate Cancer at Enrolment

Number

participants

Title

Denominators

Categories

Localized

Title	Measurements
	BG0001 BG0012 BG002

Gleason Score

The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a Gleason Score with a range of 2-10; 10=worst prognosis.

Number

participants

Title

Denominators

Categories

2-4

Title	Measurements
	BG0001 BG001

Eastern Cooporative Oncology Group (ECOG) Performance Status

Number

participants

Title

Denominators

Categories

Fully active

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

Response to treatment was defined as:

Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level

Intent to treat population. Last observation carried forward.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (baseline), 3 months

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG00024 OG00112

Title

Denominators

Categories

Response

Title	Measurements
	OG00016.67(4.74 to 37.38) OG00133.33(9.92 to 65.11)

No Response

Title	Measurements
	OG000

Secondary

Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

Response to treatment was defined as:

Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.

Per protocol, the one month timeframe was only analyzed for cohort 2.

Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (baseline), 1 month

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units

Secondary

Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

Response to treatment was defined as:

Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.

Per protocol, the two month timeframe was only analyzed for cohort 2.

Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (baseline), 2 months

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units

Secondary

Participants at Testosterone Castrate Level Throughout the Study

Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.

Intent to treat population

Posted

Number

participants

up to month 12

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Levels of Testosterone at the Last Visit

Intent to treat population with a baseline and at least one scheduled post-baseline measurement.

Posted

Mean

Standard Deviation

ng/mL

Day 0 (baseline), up to month 12 (last visit)

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit

Intent to treat population with a baseline and at least one scheduled post-baseline measurement.

Posted

Mean

Standard Deviation

ng/mL

Day 0 (baseline), up to month 12 (last visit)

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit

LH is measured in IU/L

Intent to treat population with a baseline and at least one scheduled post-baseline measurement.

Posted

Mean

Standard Deviation

percentage of baseline

Day 0 (baseline), up to month 12 (last visit)

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants

Secondary

Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit

Intent to treat population with a baseline and at least one scheduled post-baseline measurement.

Posted

Mean

Standard Deviation

IU/L

Day 0 (baseline), up to month 12 (last visit)

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Participants at Testosterone Level <=0.2 ng/mL Throughout the Study

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.

Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.

Posted

Number

participants

up to month 12

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Participants at Testosterone Level <=0.32 ng/mL Throughout the Study

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL

Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.

Posted

Number

participants

up to month 12

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study

Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.

Intent to treat population

Posted

Number

participants

up to month 12

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants	OG000

Secondary

Kaplan-Meier Estimate for Overall Survival

The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

Intent to treat population.

Analysis was not performed since no participants died during study.

Posted

up to month 12

ID	Title	Description
OG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
OG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix - Cohort 1	Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.			3	25	18	25
EG001	Degarelix - Cohort 2	Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.			1	12	10	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Systematic Assessment	EG0001 affected25 at risk EG0010 affected12 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected25 at risk EG0010 affected12 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected25 at risk EG0010 affected12 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Injection site erythema	General disorders	MedDRA (10.1)	Systematic Assessment	EG00010 affected25 at risk EG0016 affected12 at risk
Injection site swelling	General disorders	MedDRA (10.1)	Systematic Assessment	EG0008 affected25 at risk EG0015 affected12 at risk
Injection site pain	General disorders	MedDRA (10.1)	Systematic Assessment	EG0003 affected25 at risk EG0010 affected12 at risk
Injection site induration	General disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected25 at risk EG0010 affected12 at risk
General physical health deterioration	General disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Pyrexia	General disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0001 affected25 at risk EG0011 affected12 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Rhinitis	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Weight increase	Investigations	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk
Hot flush	Vascular disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected25 at risk EG0010 affected12 at risk
Venous stasis	Vascular disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected25 at risk EG0011 affected12 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases