Clinical trial · Interventional
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment due to rare targeted population
Summary
Brief summary (as posted)
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.
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
- Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
- interventionNames
- Drug: Degarelix
- type
- ACTIVE_COMPARATOR
- label
- Goserelin (3.6 mg) + bicalutamide (50 mg)
- description
- Goserelin (3.6 mg) + bicalutamide (50 mg)
- interventionNames
- Drug: Goserelin
- Drug: Bicalutamide
Primary outcomes (1)
- measure
- Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
- timeFrame
- After treatment of 12 weeks compared to Baseline
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTAnderson 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. PMID 23258223
- 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