Clinical trial · Interventional
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Degarelix | Drug | Degarelix | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Degarelix 240 mg/80 mg
- 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.
- interventionNames
- Drug: Degarelix
- type
- ACTIVE_COMPARATOR
- label
- Goserelin (3.6 mg) + bicalutamide (50 mg)
- 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.
- interventionNames
- Drug: Goserelin
- Drug: Bicalutamide
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAxcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tanko LB, Colli E, Klarskov P. Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide. BJU Int. 2012 Dec;110(11):1721-8. doi: 10.1111/j.1464-410X.2012.11107.x. Epub 2012 Apr 13. PMID 22500884
- DERIVEDZengerling 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. PMID 34350976