Prostatic Neoplasms
Conditions
Keywords
Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer
Brief summary
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Detailed description
ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
Interventions
DRUGdegarelix
periodic injection
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven prostate cancer (adenocarcinoma) of all stages * A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention * Serum testosterone level above 2.2 ng/mL * An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2 * Serum PSA level above 2 ng/mL
Exclusion criteria
* Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months * Treated with a 5α-reductase inhibitor * A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months * Concurrent or a history of severe liver disease * Abnormal ECG such as long QTc * A patient receiving ASP3550 in past times * Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time | Baseline and for one year |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum level of Luteinizing Hormone (LH) over time | Baseline and for one year |
| Changes in serum level of Follicle Stimulating Hormone (FSH) over time | Baseline and for one year |
| Changes in serum level of testosterone over time | Baseline and for one year |
| Time to the recurrence of serum PSA | For one year |
| Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests | One year |
| Changes in serum level of Prostate Specific Antigen (PSA) over time | Baseline and for one year |
Countries
Japan
Outcome results
None listed