Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00801242
• Collaborator: (none)
• Enrollment: 220
• Locations: 52
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Degarelix 240 mg / 80 mg	Phase 3

Detailed Description

The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA >4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Degarelix 240 mg / 80 mg	Drug: Degarelix 240 mg / 80 mg; For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.; Other Names: FE200486 Firmagon

Outcome Measures

Primary Outcome Measures

1. Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment [Up to 24 months after end of induction period]

   Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.

Secondary Outcome Measures

1. Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD [7 months]

2. Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment [Up to 24 months after end of induction period]

   Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.

3. Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD [7 months]

4. Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD [Up to 31 months]

   The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).

5. Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD [Up to 31 months]

   The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.

6. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment [Up to 3 x 31 months]

   This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.

7. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment [Up to 3 x 31 months]

   This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.

• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment.

• Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL.

• Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be <24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL.

• Is a male patient aged 18 years or older.

• Has an Eastern Cooperative Oncology Group score of ≤2.

• Has a life expectancy of at least 24 months.

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit.

• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

• Has hypersensitivity towards any component of the investigational medicinal product.

• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.

• Has a known or suspected clinically significant liver and/or biliary disease.

• Has a history of or risk factors for Torsades de Pointes

• At time of inclusion receives concomitant medications that might prolong the QT interval.

• Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial.

• Has a clinically significant disorder (other than prostate cancer) including but not limited to renal, haematological, 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.

• Has severe kidney failure (creatinine clearance <30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France).

• Has a mental incapacity or language barriers precluding adequate understanding or co operation.

• Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial.

• Has previously participated in any degarelix trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital St Jan Brugge	Brugge		Belgium	8000
2	Erasme Hospital, University Clinics of Brussels	Brussels		Belgium	1070
3	University Hospîtal St-Luc	Brussels		Belgium	1200
4	University Hospitals Leuven	Leuven		Belgium	3000
5	CHU Hôpital Sud	AMIENS cedex 1		France	80 054
6	Hôpital Pellegrin	BORDEAUX cedex		France	33 076
7	Centre Hospitalier René Dubos	CERGY PONTOISE cedex		France	95 303
8	Hôpital Gabriel Montpied	CLERMONT-FERRAND cedex 1		France	63 003
9	Hôpital Henri Mondor	Creteil		France	94 000
10	Hôpital Claude Huriez	LILLE cedex		France	59 037
11	Hôpital de la Conception	MARSEILLE cedex 05		France	13 385
12	Clinique Beausoleil	Montpellier		France	34 070
13	CHU Hôtel-Dieu	NANTES cedex 1		France	44 093
14	Hôpital Pasteur	NICE cedex 1		France	06 002
15	Hôpital Cochin	PARIS cedex 14		France	75 679
16	Hôpital Tenon	PARIS cedex 20		France	75 970
17	Hôpital Saint Louis	Paris		France	75 010
18	CHU Pitié Salpétrière	Paris		France	75 013
19	CHU Bichat	Paris		France	75 018
20	Centre Hospitalier Lyon Sud	Pierre Benite		France	69 310
21	CHU Le Milétrie	Poitiers		France	86 000
22	Hôpital Pontchaillou	RENNES cedex		France	35 033
23	Hôpitaux Universitaires de Strasbourg	STRASBOURG cedex		France	67 091
24	Hôpital de Rangueil	TOULOUSE cedex 9		France	31 059
25	Gemeinschaftspraxis Dres. Böhle, Rohde	Bad Schwartau		Germany	23611
26	Universitätsklinikum Düsseldorf	Düsseldorf		Germany	40255
27	Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst	Erkrath		Germany	40699
28	Urologische Gemeinschaftspraxis	Kempen		Germany	47906
29	Gemeinschaftspraxis Dres. Rudolph, Wörner	Kirchheim		Germany	73230
30	Facharzt für Urologie	Rosenheim		Germany	83022
31	Eberhard-Kars-Universität Tübingen	Tübingen		Germany	72076
32	Facharzt für Urologie	Wertingen		Germany	86637
33	Praxisgemeinschaft f. Onkologie & Urologie	Wilhelmshaven		Germany	26389
34	Praxis für Urologie	Zwickau		Germany	08060
35	Azienda Ospedaliera S. Giuseppe Moscati	Avellino		Italy	83100
36	Università degli Studi di Firenze	Bagno a Ripoli (FI)		Italy	50011
37	Azienda Policlinico Universitario G. Martino	Messina		Italy	98122
38	Ospedale S. Raffaele	Milano		Italy	20132
39	Università degli Studi di Padova	Padova		Italy	35128
40	Policlinico Univ. Agostino Gemelli	Roma		Italy	00168
41	Twenteborg Ziekenhuis	Almelo		Netherlands	7609 PP
42	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
43	Atrium MC Kerkrade	Kerkrade		Netherlands	6461 AL
44	Maatschap Urologie-Diaconessenhuis Leiden	Leiden		Netherlands	2334 CK
45	UMC St.Radboud	Nijmegen		Netherlands	6525 GA
46	Complexo Hospitalario Universitario A Coruña (CHUAC)	A Coruña		Spain	15006
47	Hospital Universitario Principe de Asturias	Alcalá de Henares, Madrid		Spain	28805
48	Hospital Universitario Vall d'Hebron	Barcelona		Spain	08035
49	Hospital Virgen de las Nieves	Granada		Spain	18014
50	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
51	Corporacio Sanitaria Parc Tauli	Sabadell		Spain	08208
52	Instituto Valenciano de Oncologia	Valencia		Spain	46009

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00801242
• Other Study ID Numbers: FE200486 CS29; 2008-003931-19
• First Posted: Dec 3, 2008
• Last Update Posted: Sep 3, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Period Title: Overall Study
STARTED	220
Safety Analysis Set	216
Full Analysis Set (FAS), Cycle 1	213
FAS, Off-treatment Cycle 1	191
Started Cycle 2	35
Started Cycle 3	2
COMPLETED	168
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Overall Participants	213
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.1 (7.73)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	213 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	212 99.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
France	43 20.2%
Spain	24 11.3%
Belgium	26 12.2%
Netherlands	25 11.7%
Germany	63 29.6%
Italy	32 15%
Median Baseline Serum Testosterone Levels (ng/mL) [Median (Full Range) ]
Median (Full Range) [ng/mL]	4.09
Median Baseline Serum Prostate-specific Antigen Levels (ng/mL) [Median (Full Range) ]
Median (Full Range) [ng/mL]	7.9
Baseline EORTC QLQ-PR25 Scores during Cycle 1 (units on a scale) [Mean (Standard Deviation) ]
Urinary Symptoms	23.1 (16.0)
Bother due to Incontinence aid	18.5 (28.0)
Bowel Symptoms	4.05 (9.65)
Hormonal Treatment-related Symptoms	7.09 (10.4)
Sexual Activity	58.0 (26.8)
Sexual Functioning	25.8 (26.7)
Baseline IIEF Scores during Cycle 1 (units on a scale) [Mean (Standard Deviation) ]
Erectile Function	7.02 (8.96)
Orgasmic Function	2.31 (3.43)
Sexual Desire	4.22 (2.26)
Intercourse Satisfaction	2.65 (4.2)
Overall Satisfaction	5.17 (2.91)

Outcome Measures

1. Primary Outcome

Title	Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment
Description	Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.
Time Frame	Up to 24 months after end of induction period

Outcome Measure Data

Analysis Population Description

FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	191
Median (95% Confidence Interval) [days]	392

2. Secondary Outcome

Title	Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

FAS, Cycle 1.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	213
Mean (Standard Deviation) [percentage of baseline]	-90.8 (16.6)

3. Secondary Outcome

Title	Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment
Description	Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.
Time Frame	Up to 24 months after end of induction period

Outcome Measure Data

Analysis Population Description

FAS, Off-treatment Cycle 1.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	191
Median (95% Confidence Interval) [days]	112

4. Secondary Outcome

Title	Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

FAS, Cycle 1.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	213
Number [participants]	210 98.6%

5. Secondary Outcome

Title	Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Description	The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Time Frame	Up to 31 months

Outcome Measure Data

Analysis Population Description

FAS, Cycle 1

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	213
Urinary Symptoms, End of Induction	24.5 (18.0)
Urinary Symptoms, End of Cycle 1	21.2 (16.7)
Bother, End of Induction	17.9 (29.1)
Bother, End of Cycle 1	31 (34.4)
Bowel Symptoms, End of Induction	4.84 (10.2)
Bowel Symptoms, End of Cycle 1	4.98 (8.34)
Treatment-related Symptoms, End of Induction	17.6 (14.5)
Treatment-related Symptoms, End of Cycle 1	13.2 (13.0)
Sexual Activity, End of Induction	55.1 (27.2)
Sexual Activity, End of Cycle 1	56.7 (26.6)
Sexual Functioning, End of Induction	10.9 (17.7)
Sexual Functioning, End of Cycle 1	17.7 (22.6)

6. Secondary Outcome

Title	Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Description	The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.
Time Frame	Up to 31 months

Outcome Measure Data

Analysis Population Description

FAS, Cycle 1.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	213
Erectile Function, End of Induction	3.1 (5)
Erectile Function, End of Cycle 1	5.35 (8.21)
Orgasmic Function, End of Induction	0.665 (1.81)
Orgasmic Function, End of Cycle 1	1.76 (3.03)
Sexual Desire, End of Induction	2.84 (1.47)
Sexual Desire, End of Cycle 1	3.77 (2.17)
Intercourse Satisfaction, End of Induction	0.801 (2.21)
Intercourse Satisfaction, End of Cycle 1	2.01 (3.69)
Overall Satisfaction, End of Induction	4.5 (2.9)
Overall Satisfaction, End of Cycle 1	4.97 (3.12)

7. Secondary Outcome

Title	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Description	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.
Time Frame	Up to 3 x 31 months

Outcome Measure Data

Analysis Population Description

Safety Analysis Set.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	216
Systolic blood pressure ≤90 and decrease ≥20	4 1.9%
Systolic blood pressure ≥180 and increase ≥20	13 6.1%
Diastolic blood pressure ≤50 and decrease ≥15	2 0.9%
Diastolic blood pressure ≥105 and increase ≥15	8 3.8%
Heart rate ≤50 and decrease ≥15	4 1.9%
Heart rate ≥120 and increase ≥15	0 0%
Body weight decrease of ≥7 percent	14 6.6%
Body weight increase of ≥7 percent	23 10.8%

8. Secondary Outcome

Title	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
Description	This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.
Time Frame	Up to 3 x 31 months

Outcome Measure Data

Analysis Population Description

Safety Analysis Set.

Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Measure Participants	216
S-Alanine Aminotransferase, >3xULN	2 0.9%
S-Alkaline Phosphatase, >3xULN and 25% increase	1 0.5%
S-Aspartate Aminotransferase, >3xULN	2 0.9%
S-Calcium, ≤1.8 mmol/L	1 0.5%
S-Creatinine, ≥177 (µmol/L)	1 0.5%
S-Glutamyltransferase, >3xULN	1 0.5%
S-Potassium, ≥5.8 mmol/L)	3 1.4%
S-Total Bilirubin, >1.5xULN	1 0.5%
S-Urea Nitrogen, >10.7 mmol/L	24 11.3%
S-Sodium, ≤130 mmol/L	1 0.5%

Adverse Events

Time Frame	3 x 31 months.
Adverse Event Reporting Description	Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Arm/Group Title	Degarelix 240 mg / 80 mg
Arm/Group Description	Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
All Cause Mortality
	Degarelix 240 mg / 80 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Degarelix 240 mg / 80 mg
	Affected / at Risk (%)	# Events
Total	51/216 (23.6%)
Cardiac disorders
Cardiac Failure	2/216 (0.9%)
Coronary Artery Stenosis	2/216 (0.9%)
Myocardial Infarction	2/216 (0.9%)
Aortic Valve Stenosis	1/216 (0.5%)
Bradyarrhythmia	1/216 (0.5%)
Diastolic Dysfunction	1/216 (0.5%)
Sick Sinus Syndrome	1/216 (0.5%)
Ear and labyrinth disorders
Vertigo	1/216 (0.5%)
Eye disorders
Blindness Transient	1/216 (0.5%)
Gastrointestinal disorders
Gastric Ulcer	2/216 (0.9%)
Inguinal Hernia	2/216 (0.9%)
Gastrointestinal Haemorrhage	2/216 (0.9%)
Tongue Disorder	1/216 (0.5%)
General disorders
Chest Pain	1/216 (0.5%)
Injection Site Oedema	1/216 (0.5%)
Injection Site Pain	1/216 (0.5%)
Injection Site Swelling	1/216 (0.5%)
Oedema Peripheral	1/216 (0.5%)
Hepatobiliary disorders
Cholelithiasis	1/216 (0.5%)
Infections and infestations
Pneumonia	2/216 (0.9%)
Abscess	1/216 (0.5%)
Gastroenteritis Viral	1/216 (0.5%)
Lung Infection	1/216 (0.5%)
Pneumocystis Jiroveci Pneumonia	1/216 (0.5%)
Pyelonephritis Acute	1/216 (0.5%)
Urinary Tract Infection	1/216 (0.5%)
Erysipelas	1/216 (0.5%)
Injury, poisoning and procedural complications
Dislocation of Joint Prosthesis	1/216 (0.5%)
Metabolism and nutrition disorders
Diabetes Mellitus	1/216 (0.5%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	4/216 (1.9%)
Intervertebral Disc Protrusion	1/216 (0.5%)
Pain in Extremity	1/216 (0.5%)
Polyarthritis	1/216 (0.5%)
Synovial Cyst	1/216 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer	1/216 (0.5%)
Bladder Cancer	1/216 (0.5%)
Non-Hodgkin's Lymphoma	1/216 (0.5%)
Prostate Cancer Recurrent	1/216 (0.5%)
Squamous Cell Carcinoma of Skin	1/216 (0.5%)
Lung Neoplasm Malignant	1/216 (0.5%)
Nervous system disorders
Carotid Artery Stenosis	2/216 (0.9%)
Cerebral Infarction	1/216 (0.5%)
Brain Stem Ischaemia	1/216 (0.5%)
Cerebral Ischaemia	1/216 (0.5%)
Dementia	1/216 (0.5%)
Embolic Cerebral Infarction	1/216 (0.5%)
Neuropathy	1/216 (0.5%)
Psychiatric disorders
Delirium	1/216 (0.5%)
Renal and urinary disorders
Bladder Neck Sclerosis	1/216 (0.5%)
Haematuria	1/216 (0.5%)
Pollakiuria	1/216 (0.5%)
Renal Artery Stenosis	1/216 (0.5%)
Renal Failure	1/216 (0.5%)
Urethral Stenosis	1/216 (0.5%)
Urinary Retention	1/216 (0.5%)
Urinary Tract Pain	1/216 (0.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional	2/216 (0.9%)
Chronic Obstructive Pulmonary Disease	1/216 (0.5%)
Pulmonary Embolism	1/216 (0.5%)
Vascular disorders
Vascular Pseudoaneurysm	1/216 (0.5%)
Hypotension	1/216 (0.5%)
Other (Not Including Serious) Adverse Events
	Degarelix 240 mg / 80 mg
	Affected / at Risk (%)	# Events
Total	185/216 (85.6%)
Gastrointestinal disorders
Diarrhoea	16/216 (7.4%)
General disorders
Injection Site Pain	73/216 (33.8%)
Injection Site Erythema	63/216 (29.2%)
Injection Site Swelling	48/216 (22.2%)
Injection Site Induration	31/216 (14.4%)
Fatigue	30/216 (13.9%)
Oedema Peripheral	13/216 (6%)
Asthenia	12/216 (5.6%)
Injection Site Pruritus	11/216 (5.1%)
Infections and infestations
Nasopharyngitis	24/216 (11.1%)
Investigations
Weight Increased	29/216 (13.4%)
Musculoskeletal and connective tissue disorders
Back Pain	15/216 (6.9%)
Nervous system disorders
Headache	11/216 (5.1%)
Renal and urinary disorders
Pollakiuria	12/216 (5.6%)
Vascular disorders
Hot Flush	107/216 (49.5%)
Hypertension	22/216 (10.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.