Phase 2
N=189
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00819156 ↗Enrolled (actual)
189
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 — 17; 21; 26; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- degarelix (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jun 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 |
17; 21; 26; 27; 27; 23 | — |
| SECONDARY Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28 |
44; 48; 49 | — |
| SECONDARY Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. |
21; 29; 31; 29; 31; 27 | — |
| SECONDARY Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. |
25; 30; 27; 28; 30; 28 | — |
| SECONDARY Days to 50 Percent Reduction in Prostate-Specific Antigen |
14; 14; 14; 14; 14; 14 | 0.0933 |
| SECONDARY Days to 90 Percent Reduction in Prostate-Specific Antigen |
56; 56; 56; 56; 56; 56 | 0.165 |
| SECONDARY Days to Prostate-Specific Antigen Progression |
224; 308; 280; 224; 140 | 0.429 |
| SECONDARY Median Serum Testosterone Levels |
4.47; 3.93; 4.79; 4.28; 4.07; 3.88 | — |
| SECONDARY Median Prostate-specific Antigen Levels |
15.2; 31.5; 31.5; 23.1; 35.3; 32 | — |
| SECONDARY Median Values of Di-Hydrotestosterone |
430; 330; 310; 330; 350; 290 | — |
| SECONDARY Median Values for Serum Luteinizing Hormone |
3.8; 4; 5.05; 5.6; 3.9; 6 | — |
| SECONDARY Median Values for Follicle Stimulation Hormone |
8.35; 9.25; 9; 9.7; 7; 10.2 | — |
| SECONDARY The Number of Patients With Abnormal Liver Function Tests |
6; 10; 15; 13; 8; 9 | — |
| SECONDARY The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight |
0; 0; 0; 2; 2; 2 | — |
Summary
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to any study related procedures
- Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
- ECOG score to be equal to or above 2
- Testosterone level within age-specific normal range
- PSA value equal to or above 2 ng/ml
- Life expectancy of at least 6 months
Exclusion Criteria
- Previous or current hormonal treatment of prostate cancer
- Recent or current treatment with any drugs modifying the testosterone level
- Candidate for curative treatment such as prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
- Hypersensitivity towards any component of degarelix or mannitol
- Cancer disease within the last 5 years except for prostate cancer and some skin cancers
- Signs of liver impairment shown as elevated serum ALT or serum bilirubin
- Known hepatic disease
- Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
- Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- Mental incapacity or language barrier precluding adequate understanding or cooperation
- Having received an investigational product within the last 12 weeks preceding the trial
- Previous participation in this trial
Data sourced from ClinicalTrials.gov (NCT00819156). 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.