Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix Drug: Goserelin Drug: Bicalutamide	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide Goserelin acetate Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) [ Time Frame: After treatment of 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
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) [ Time Frame: After treatment of 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change From Baseline in Serum Oestradiol Levels During the Study [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
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.

Enrollment:	246
Study Start Date:	April 2009
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix 240 mg/80 mg 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.	Drug: Degarelix 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. Other Names: FE200486 Firmagon
Active Comparator: Goserelin (3.6 mg) + bicalutamide (50 mg) 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.	Drug: Goserelin 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. Other Name: Zoladex Drug: Bicalutamide 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. Other Name: Casodex

Arms

Assigned Interventions

Experimental: Degarelix 240 mg/80 mg

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.

Drug: Degarelix

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.

Other Names:

FE200486
Firmagon

Active Comparator: Goserelin (3.6 mg) + bicalutamide (50 mg)

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.

Drug: Goserelin

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.

Other Name: Zoladex

Drug: Bicalutamide

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.

Other Name: Casodex

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833248

Show 66 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00833248 History of Changes
Other Study ID Numbers:	FE200486 CS30, 2008-005232-33
Study First Received:	January 30, 2009
Results First Received:	August 27, 2012
Last Updated:	September 27, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Greece: National Organization of Medicines Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Bicalutamide
Androgens

Goserelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013