Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Degarelix

Goserelin

Bicalutamide

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:

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
Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
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)
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.
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.

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

Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)

Goserelin (3.6 mg) + bicalutamide (50 mg)

Outcomes

Primary Outcome Measures

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 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.

Secondary Outcome Measures

Change From Baseline in Total IPSS at Weeks 4 and 8

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 Maximum Urine Flow (Qmax) at Each Visit

Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)

Change From Baseline in Residual Volume (Vresidual) at Each Visit

Uroflowmetry was used to quantify the residual volume (Vresidual; mL)

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12

TRUS is a method of measuring the size of the prostate.

Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit

Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit

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'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.

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 on participant with one abnormal value are presented, many more variables were included in the trial.

Full Information

NCT ID

NCT00831233

First Posted

January 27, 2009

Last Updated

October 18, 2013

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00831233

Brief Title

Symptomatic 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 Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment due to rare targeted population

Study Start Date

April 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

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

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Degarelix 240 mg/80 mg

Arm Type

Experimental

Arm Description

Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)

Arm Title

Goserelin (3.6 mg) + bicalutamide (50 mg)

Arm Type

Active Comparator

Arm Description

Goserelin (3.6 mg) + bicalutamide (50 mg)

Intervention Type

Drug

Intervention Name(s)

Degarelix

Other Intervention Name(s)

FE200486

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 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, three days before the first dose of goserelin on Day 3, patients 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 Total International Prostate Symptom Score (IPSS) at Week 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 12 weeks compared to Baseline

Secondary Outcome Measure Information:

Title

Change From Baseline in Total IPSS at Weeks 4 and 8

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 and 8 weeks compared to Baseline

Title

Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit

Description

Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)

Time Frame

After treatment of 4, 8 and 12 weeks compared to Baseline

Title

Change From Baseline in Residual Volume (Vresidual) at Each Visit

Description

Uroflowmetry was used to quantify the residual volume (Vresidual; mL)

Time Frame

After treatment of 4, 8 and 12 weeks compared to Baseline

Title

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12

Description

TRUS is a method of measuring the size of the prostate.

Time Frame

After 12 weeks treatment compared to Baseline

Title

Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit

Time Frame

After treatment of 4, 8 and 12 weeks compared to Baseline

Title

Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit

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'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.

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 on participant with one abnormal value are presented, many more variables were included in the trial.

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 Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist. Patients in need of external beam radiotherapy to be started at the same time as hormone therapy 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) 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. 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

Facharztpraxis für Urologie

City

Bamberg

ZIP/Postal Code

96047

Country

Germany

Facility Name

Gemeinschaftspraxis

City

Borken

ZIP/Postal Code

46325

Country

Germany

Facility Name

Universitätsklinikum Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Euromed Clinic

City

Fürth

ZIP/Postal Code

90763

Country

Germany

Facility Name

Urologische Gemeinschaftspraxis

City

Hamburg

ZIP/Postal Code

22399

Country

Germany

Facility Name

Gemeinschaftspraxis

City

Köln

ZIP/Postal Code

50667

Country

Germany

Facility Name

VITURO Gesellschaft für Klinische Studien

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Klinikum Offenbach GmbH

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Urologische Klinik Planegg

City

Planegg

ZIP/Postal Code

82152

Country

Germany

Facility Name

Wuppertaler Gemeinschaftspraxis

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Hospital Universitario Principe de Asturias

City

Alcalá de Henares-Madrid

ZIP/Postal Code

28805

Country

Spain

Facility Name

Fundacion Hospital Alcorcón

City

Alcorcon

ZIP/Postal Code

28922

Country

Spain

Facility Name

Fundación Puigvert

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital de Basurto

City

Bilbao (Bizkaia)

ZIP/Postal Code

48013

Country

Spain

Facility Name

Complejo Hospitalario Universitario A Coruña

City

Coruña

Country

Spain

Facility Name

Hospital universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Clinico Universitario S. Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro

City

Majadahonda, Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Manacor

City

Manacor

ZIP/Postal Code

07500

Country

Spain

Facility Name

Hospital Universitario Central de Asturias

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Hospital Santiago de Compostela

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Virgen Macarena

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Hospital Xeral de Vigo

City

Vigo

ZIP/Postal Code

36204

Country

Spain

Facility Name

United Bristol Healthcare NHSTrust Bristol Royal Infirmary

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

Falkirk and District Royal Infirmary

City

Falkirk

ZIP/Postal Code

FK1 5QE

Country

United Kingdom

Facility Name

Southern General Hospital

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Castle Hill Hospital

City

Hull

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Whipps Cross University Hospital

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

The Royal Free Hospital

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

King's College Hospital

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Derriford Hospital

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Royal Hallamshire Hospital, Sheffield South

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Sunderland Royal Hospital

City

Sunderland

ZIP/Postal Code

SR4 7TP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23258223

Citation

Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.

Results Reference

result

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

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial