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Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix 240 mg / 80 mg
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital St Jan Brugge
  • Erasme Hospital, University Clinics of Brussels
  • University Hospîtal St-Luc
  • University Hospitals Leuven
  • CHU Hôpital Sud
  • Hôpital Pellegrin
  • Centre Hospitalier René Dubos
  • Hôpital Gabriel Montpied
  • Hôpital Henri Mondor
  • Hôpital Claude Huriez
  • Hôpital de la Conception
  • Clinique Beausoleil
  • CHU Hôtel-Dieu
  • Hôpital Pasteur
  • Hôpital Cochin
  • Hôpital Tenon
  • Hôpital Saint Louis
  • CHU Pitié Salpétrière
  • CHU Bichat
  • Centre Hospitalier Lyon Sud
  • CHU Le Milétrie
  • Hôpital Pontchaillou
  • Hôpitaux Universitaires de Strasbourg
  • Hôpital de Rangueil
  • Gemeinschaftspraxis Dres. Böhle, Rohde
  • Universitätsklinikum Düsseldorf
  • Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst
  • Urologische Gemeinschaftspraxis
  • Gemeinschaftspraxis Dres. Rudolph, Wörner
  • Facharzt für Urologie
  • Eberhard-Kars-Universität Tübingen
  • Facharzt für Urologie
  • Praxisgemeinschaft f. Onkologie & Urologie
  • Praxis für Urologie
  • Azienda Ospedaliera S. Giuseppe Moscati
  • Università degli Studi di Firenze
  • Azienda Policlinico Universitario G. Martino
  • Ospedale S. Raffaele
  • Università degli Studi di Padova
  • Policlinico Univ. Agostino Gemelli
  • Twenteborg Ziekenhuis
  • Universitair Medisch Centrum Groningen
  • Atrium MC Kerkrade
  • Maatschap Urologie-Diaconessenhuis Leiden
  • UMC St.Radboud
  • Complexo Hospitalario Universitario A Coruña (CHUAC)
  • Hospital Universitario Principe de Asturias
  • Hospital Universitario Vall d'Hebron
  • Hospital Virgen de las Nieves
  • Hospital Universitario 12 de Octubre
  • Corporacio Sanitaria Parc Tauli
  • Instituto Valenciano de Oncologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix 240 mg / 80 mg

Arm Description

Outcomes

Primary Outcome Measures

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
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

Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
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
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.
Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD
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
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).
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
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.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
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.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
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.

Full Information

First Posted
December 2, 2008
Last Updated
September 2, 2014
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00801242
Brief Title
Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 240 mg / 80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degarelix 240 mg / 80 mg
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Hospital St Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Erasme Hospital, University Clinics of Brussels
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University Hospîtal St-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Hôpital Sud
City
AMIENS cedex 1
ZIP/Postal Code
80 054
Country
France
Facility Name
Hôpital Pellegrin
City
BORDEAUX cedex
ZIP/Postal Code
33 076
Country
France
Facility Name
Centre Hospitalier René Dubos
City
CERGY PONTOISE cedex
ZIP/Postal Code
95 303
Country
France
Facility Name
Hôpital Gabriel Montpied
City
CLERMONT-FERRAND cedex 1
ZIP/Postal Code
63 003
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94 000
Country
France
Facility Name
Hôpital Claude Huriez
City
LILLE cedex
ZIP/Postal Code
59 037
Country
France
Facility Name
Hôpital de la Conception
City
MARSEILLE cedex 05
ZIP/Postal Code
13 385
Country
France
Facility Name
Clinique Beausoleil
City
Montpellier
ZIP/Postal Code
34 070
Country
France
Facility Name
CHU Hôtel-Dieu
City
NANTES cedex 1
ZIP/Postal Code
44 093
Country
France
Facility Name
Hôpital Pasteur
City
NICE cedex 1
ZIP/Postal Code
06 002
Country
France
Facility Name
Hôpital Cochin
City
PARIS cedex 14
ZIP/Postal Code
75 679
Country
France
Facility Name
Hôpital Tenon
City
PARIS cedex 20
ZIP/Postal Code
75 970
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75 010
Country
France
Facility Name
CHU Pitié Salpétrière
City
Paris
ZIP/Postal Code
75 013
Country
France
Facility Name
CHU Bichat
City
Paris
ZIP/Postal Code
75 018
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69 310
Country
France
Facility Name
CHU Le Milétrie
City
Poitiers
ZIP/Postal Code
86 000
Country
France
Facility Name
Hôpital Pontchaillou
City
RENNES cedex
ZIP/Postal Code
35 033
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
STRASBOURG cedex
ZIP/Postal Code
67 091
Country
France
Facility Name
Hôpital de Rangueil
City
TOULOUSE cedex 9
ZIP/Postal Code
31 059
Country
France
Facility Name
Gemeinschaftspraxis Dres. Böhle, Rohde
City
Bad Schwartau
ZIP/Postal Code
23611
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40255
Country
Germany
Facility Name
Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst
City
Erkrath
ZIP/Postal Code
40699
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis
City
Kempen
ZIP/Postal Code
47906
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Rudolph, Wörner
City
Kirchheim
ZIP/Postal Code
73230
Country
Germany
Facility Name
Facharzt für Urologie
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Eberhard-Kars-Universität Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Facharzt für Urologie
City
Wertingen
ZIP/Postal Code
86637
Country
Germany
Facility Name
Praxisgemeinschaft f. Onkologie & Urologie
City
Wilhelmshaven
ZIP/Postal Code
26389
Country
Germany
Facility Name
Praxis für Urologie
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Azienda Ospedaliera S. Giuseppe Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Università degli Studi di Firenze
City
Bagno a Ripoli (FI)
ZIP/Postal Code
50011
Country
Italy
Facility Name
Azienda Policlinico Universitario G. Martino
City
Messina
ZIP/Postal Code
98122
Country
Italy
Facility Name
Ospedale S. Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Università degli Studi di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico Univ. Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Twenteborg Ziekenhuis
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Atrium MC Kerkrade
City
Kerkrade
ZIP/Postal Code
6461 AL
Country
Netherlands
Facility Name
Maatschap Urologie-Diaconessenhuis Leiden
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
Facility Name
UMC St.Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Complexo Hospitalario Universitario A Coruña (CHUAC)
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Principe de Asturias
City
Alcalá de Henares, Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28753747
Citation
Abrahamsson PA, Boccon-Gibod L, Morote J, de Jong IJ, Malmberg A, Neijber A, Albers P. Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy. Eur Urol Focus. 2017 Oct;3(4-5):470-479. doi: 10.1016/j.euf.2015.12.008. Epub 2016 Jan 22.
Results Reference
derived
PubMed Identifier
24954791
Citation
Boccon-Gibod L, Albers P, Morote J, van Poppel H, de la Rosette J, Villers A, Malmberg A, Neijber A, Montorsi F. Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer. Eur Urol. 2014 Oct;66(4):655-63. doi: 10.1016/j.eururo.2014.05.037. Epub 2014 Jun 18.
Results Reference
derived

Learn more about this trial

Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

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