Phase 3
Completed N=182
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Source: ClinicalTrials.gov NCT00884273 ↗Enrolled (actual)
182
Serious AEs
4.4%
Results posted
Apr 2012
Primary outcomePrimary: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) — -37.2; -39.0 milliliter — p=0.36
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) |
-37.2; -39.0 | 0.36 |
| PRIMARY Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) |
-37.3; -39.0 | 0.41 |
| SECONDARY Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 |
-19.2; -21.2; -33.1; -33.2 | — |
| SECONDARY Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 |
-2.09; -1.36; -3.55; -3.13; -4.39; -2.74 | — |
| SECONDARY Change in Serum Testosterone Levels During the Study |
-3.91; -4.17; -3.97; -4.24; -4.09; -4.23 | — |
| SECONDARY Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study |
-20.25; -12.10; -22.5; -14.6; -25.15; -13.1 | — |
| SECONDARY Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit |
-0.46; -0.56; -0.83; -0.79; -0.99; -1.01 | — |
| SECONDARY Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) |
-0.78; -0.70; -0.88; -1.09; -1.28; -1.16 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables |
13; 16; 2; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has given written informed consent
- Patient is 18 years or older
- Patient has histologically confirmed prostate cancer
- Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL
- The prostate size is >30 cubic centimetres (cc), measured by TRUS
- Patient has had a bone-scan within 12 weeks before inclusion
- Patient must be able to undergo transrectal examinations
- Patient has an estimated life expectancy of at least 12 months
Exclusion Criteria
- Any previous treatments for prostate cancer
- Previous trans-urethral resection of the prostate (TURP)
- Is not considered a candidate for medical castration
- Use of urethral catheter
- Is currently treated with a 5-alpha reductase inhibitor
- Is currently treated with an alpha-adrenoceptor antagonist
- Treatment with botulinum toxin A (Botox)
- Require radiotherapy during the trial
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- Hypersensitivity towards any component of the investigational products or excipients
- Previous history or presence of another malignancy
- A clinically significant disorder
- A corrected QT interval over 450 msec
- Mental incapacity or language barrier precluding adequate understanding or co-operation
- Receipt of an investigational drug within the last 28 days proceeding screening
- Previous participation in any degarelix trial
Data sourced from ClinicalTrials.gov (NCT00884273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.