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

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Bicalutamide; Drug: Goserelin; Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884273

FE200486 CS31

2008-008604-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Degarelix 240 mg/80 mg

Experimental group

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.

Treatment:

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

Active Comparator group

Description:

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. 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 28 days after the first dose of goserelin.

Treatment:

Drug: Goserelin

Drug: Bicalutamide