Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Ferring Pharmaceuticals182 enrolled

Overview

This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Prostate Cancer

Interventions

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient has given written informed consent 2. Patient is 18 years or older 3. Patient has histologically confirmed prostate cancer 4. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL 5. The prostate size is \>30 cubic centimetres (cc), measured by TRUS 6. Patient has had a bone-scan within 12 weeks before inclusion 7. Patient must be able to undergo transrectal examinations 8. Patient has an estimated life expectancy of at least 12 months Exclusion Criteria: 1. Any previous treatments for prostate cancer 2. Previous trans-urethral resection of the prostate (TURP) 3. Is not considered a candidate for medical castration 4. Use of urethral catheter 5. Is currently treated with a 5-alpha reductase inhibitor 6. Is currently treated with an alpha-adrenoceptor antagonist 7. Treatment with botulinum toxin A (Botox) 8. Require radiotherapy during the trial 9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 10. Hypersensitivity towards any component of the investigational products or excipients 11. Previous history or presence of another malignancy 12. A clinically significant disorder 13. A corrected QT interval over 450 msec 14. Mental incapacity or language barrier precluding adequate understanding or co-operation 15. Receipt of an investigational drug within the last 28 days proceeding screening 16. Previous participation in any degarelix trial

Locations (46)

Hospital St Jan Brugge

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

University Hospitals Leuven

Leuven, Belgium

St. Elisabethziekenhuis

Turnhout, Belgium

Aalborg Sygehus syd

Aalborg, Denmark

Århus Universitetshospital, Skejby

Outcomes

Primary Outcomes

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.

Time frame: After treatment of 12 weeks compared to Baseline

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.

Time frame: After treatment of 12 weeks compared to Baseline

Secondary Outcomes

Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8

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

Time frame: After treatment of 4 and 8 weeks compared to Baseline

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.

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

Change in Serum Testosterone Levels During the Study

Time frame: At 4, 8, and 12 weeks compared to baseline.

Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study

Time frame: At 4, 8, and 12 weeks compared to baseline.

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').

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

Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)

The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.

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

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.

Time frame: Baseline to 12 weeks of treatment

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.

Time frame: Baseline to 12 weeks of treatment