Prostate Cancer
Conditions
Brief summary
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Interventions
DRUGDegarelix
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated * Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan * Has a PSA level meeting one of these criteria: 1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL. 2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements 3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir * Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as \>150 ng/dL * Has an Eastern Cooperative Oncology Group score of ≤2 * Has a life expectancy of at least one year
Exclusion criteria
* Has had previous or is currently under hormonal management of prostate cancer * Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period * Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy * Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms) * Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome) * Has a previous history or presence of another malignancy, other than prostate * Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle * Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax) | Day 0-28 and at Day 112-140 | — |
| Trough plasma levels (blood sample analysis) | Day 28, 56, 84, 112, 140, 168 and 196 | Actual levels prior to dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of testosterone and PSA | From baseline to Day 196 | — |
| Percentage change in PSA levels | From baseline to Day 196 | — |
| Changes in patient-reported injection site pain (VAS scores over time) | At 5 minutes and at 60 minutes after each injection | Will compare starting dose to maintenance doses |
| Clinically significant changes in laboratory values | From baseline to Day 196 | — |
| Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs | From baseline to Day 196 | — |
| Incidence and severity of investigator-evaluated injection site reactions | From baseline to Day 196 | — |
| Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit | From Day 28 onwards (up to Day 196) | — |
| Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL) | From Day 28 to Day 364 | — |
| Clinically significant changes in ECGs, vital signs, physical examinations, and body weight | From baseline to Day 196 | — |
| Proportion of patients without clinically significant pain (VAS score of ≤10 mm) | 60 minutes after each dosing injection | — |
| Proportion of patients with testosterone ≤0.5 ng/mL | From baseline to Day 196 | — |
Countries
Canada, United States
Outcome results
None listed