Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Summary
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.
Timeline
- Start
- 2009-04
- Primary completion
- 2010-06
- Completion
- 2010-07
Outcome
Met primary endpoint
Stopped (Enrollment): “Poor recruitment due to rare targeted population”
paper Degarelix was non-inferior to G+B in reducing IPSS at week 12 in the full analysis set (p = 0.20); PMID 23258223 ↗
paper degarelix was at least non-inferior to G+B in reducing IPSS at week 12. PMID 23258223 ↗
Publications
- Results Anderson 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.
- Zengerling 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Degarelix | Other / unclassified | 80 mg | Subcutaneous |
| Comparator | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |