Prostate Cancer
Conditions
Keywords
ASP3550, Prostate cancer
Brief summary
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
Detailed description
This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer. The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.
Interventions
DRUGdegarelix
subcutaneous
DRUGGoserelin
subcutaneous
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
* Male patient with histologically confirmed prostate cancer (adenocarcinoma). * Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included. * Has a serum testosterone level above 2.2 ng/mL at screening. * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening. * Has a serum PSA ≥ 2 ng/mL at screening. * Has a life expectancy of at least 12 months.
Exclusion criteria
* Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors. * Received a 5α-reductase inhibitor within 25 weeks preceding screening. * Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months. * Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema. * Has hypersensitivity towards mannitol. * Has a marked prolongation of QT/QTc interval (two consecutive increases to \>450 ms in QTc interval at retest) at screening. * Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative castration rate of treatment in terms of serum testosterone level | Up to one year of the treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of castrated subjects in terms of serum testosterone level | Up to one year of the treatment |
| Changes in serum levels of prostate-specific antigen (PSA) over time | Up to one year of the treatment |
| Safety assessed by the incidence of adverse events | up to the end of treatment. approximately for 2 years |
Countries
Japan
Outcome results
None listed