Back to resultsNeoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix
Goserelin
Bicalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient has given written informed consent before any trial-related activity is performed.
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria:
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Sites / Locations
- Alabama Research Center
- Urology Centers of Alabama
- Alaska Urological Association
- Arizona Urologic Specialists
- Orange County Urology
- Tri-Valley Urology Medical Group
- Connecticut Clinical Research Center
- South Florida Medical Research
- DCT -Celebration, LLC dba Discovery Clinical Trials
- Pinellas Urology Inc.
- Palm Beach Urology Associates
- Summit Research Institute
- Northeast Indiana Research
- Urology Center Research Institute
- Urology Group of New Mexico
- Premier Medical Group of Hudson
- University Urology Associates
- Urology Associates
- Urology of Virginia
- Hopital Jean Minjoz
- Institut Bergonié
- Centre Francois Baclesse
- CHU Henri Mondor
- Centre Oscar Lambret
- Centre Leon Berard
- Hopital de la Timone
- CRLC Val d'Aurelle Oncology Radiotherapy
- Hôpital Tenon
- Hôpital Saint Louis, Radiotherapy Departement
- Clinique Francheville
- CHU La Milétrie, Oncology Radiotherapy
- Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
- Institut de Cancérologie de la Loire
- Clinique Saint Brieuc
- Centre Paul Strauss
- Centre de radiologie Saint Louis
- Clinique du Parc
- IGR
- Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie
- Städtisches Klinikum Braunschweig
- Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie
- Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie
- General University Hospital of Alexandroupolis
- General Hospital of Athens, "Sismanogleio", University of Athens, Marouse
- University General Hospital of Loannina, Medical School
- University General Hospital of Patras
- Albert Schweitzer Ziekenhuis, Ioc., Dordwijk
- Groene Hart Ziekenhuis, urology
- Franciscus Gasthuis, Dept. urology
- Maastad Ziekenhuis, Ioc. Clara
- Vlietland Ziekenhuis, Dept. urology
- St. Elisabeth Ziekenhuis Tilburg
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d´Hebron
- Hospital Universitario La Paz
- Fundación IVO
- Kent Oncology Centre Maidstone Hospital
- Mount Vernon Cancer Center
- Oncology Royal United Hospital Bath NHS Trust
- Addenbrooke's Hospital, Oncology Centre
- St. James' University Hospital
- The Royal Marsden NHS, Foundation Trust
- Charing Cross Hospital
- Northern Centre for Cancer Treatment, Newcastle General Hospital
- Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre
- Velindre Hospital, Cardiff University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Degarelix 240 mg/80 mg
Goserelin (3.6 mg) + bicalutamide (50 mg)
Arm Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Outcomes
Primary Outcome Measures
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
TRUS is a method of measuring the size of the prostate.
Secondary Outcome Measures
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Change From Baseline in Serum Testosterone Levels During the Study
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Change From Baseline in Serum Oestradiol Levels During the Study
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Full Information
NCT ID
NCT00833248
First Posted
January 30, 2009
Last Updated
September 27, 2012
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00833248
Brief Title
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Official Title
A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix 240 mg/80 mg
Arm Type
Experimental
Arm Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Arm Title
Goserelin (3.6 mg) + bicalutamide (50 mg)
Arm Type
Active Comparator
Arm Description
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
Zoladex
Intervention Description
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
Primary Outcome Measure Information:
Title
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Description
TRUS is a method of measuring the size of the prostate.
Time Frame
After treatment of 12 weeks compared to Baseline
Title
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
Description
TRUS is a method of measuring the size of the prostate.
Time Frame
After treatment of 12 weeks compared to Baseline
Secondary Outcome Measure Information:
Title
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Description
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change From Baseline in Serum Testosterone Levels During the Study
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change From Baseline in Serum Oestradiol Levels During the Study
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
Description
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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.
Time Frame
Baseline to 12 weeks of treatment
Title
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame
Baseline to 12 weeks of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has given written informed consent before any trial-related activity is performed.
Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria:
Previous treatment for prostate cancer
Previous trans-urethral resection of the prostate
Patients who are lymph node positive or have other metastatic disease
Use of urethral catheter
Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Hypersensitivity towards any component of the investigational product
Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
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
Alabama Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alaska Urological Association
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Urologic Specialists
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orange County Urology
City
Lagua Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Tri-Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
DCT -Celebration, LLC dba Discovery Clinical Trials
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Pinellas Urology Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Palm Beach Urology Associates
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Summit Research Institute
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Urology Center Research Institute
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Premier Medical Group of Hudson
City
Columbia
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Urology of Virginia
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital de la Timone
City
Marseille, Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
CRLC Val d'Aurelle Oncology Radiotherapy
City
Montpellier
ZIP/Postal Code
CX5 34298
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hôpital Saint Louis, Radiotherapy Departement
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Clinique Francheville
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
CHU La Milétrie, Oncology Radiotherapy
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
City
Saint Herblain Cedex
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
CX 42271
Country
France
Facility Name
Clinique Saint Brieuc
City
St Brieuc Cedex
ZIP/Postal Code
22015
Country
France
Facility Name
Centre Paul Strauss
City
Strassbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Centre de radiologie Saint Louis
City
Toulon
ZIP/Postal Code
83100
Country
France
Facility Name
Clinique du Parc
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
IGR
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie
City
Berlin
ZIP/Postal Code
D-12203
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
D-38126
Country
Germany
Facility Name
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
General University Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
General Hospital of Athens, "Sismanogleio", University of Athens, Marouse
City
Athens
ZIP/Postal Code
15126
Country
Greece
Facility Name
University General Hospital of Loannina, Medical School
City
Loannina
ZIP/Postal Code
45110
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis, urology
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Franciscus Gasthuis, Dept. urology
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Maastad Ziekenhuis, Ioc. Clara
City
Rotterdam
ZIP/Postal Code
3078HT
Country
Netherlands
Facility Name
Vlietland Ziekenhuis, Dept. urology
City
Schiedam
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis Tilburg
City
Tilburg
ZIP/Postal Code
5000 LC
Country
Netherlands
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Fundación IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Kent Oncology Centre Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Mount Vernon Cancer Center
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Oncology Royal United Hospital Bath NHS Trust
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Addenbrooke's Hospital, Oncology Centre
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
St. James' University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Royal Marsden NHS, Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8FR
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment, Newcastle General Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre
City
Southhampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Velindre Hospital, Cardiff University
City
Whitchurch
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34350976
Citation
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Results Reference
derived
PubMed Identifier
23257248
Citation
Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.
Results Reference
derived
Learn more about this trial
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
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