A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer
- Registration Number
- NCT01964170
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 234
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP3550 PART 1 and PART 2 degarelix Part 1 for 1 year treatment and Part 2 for an extended period of treatment Goserelin Goserelin part 1 for 1 year treatment
- Primary Outcome Measures
Name Time Method Cumulative castration rate of treatment in terms of serum testosterone level Up to one year of the treatment
- Secondary Outcome Measures
Name Time Method Proportion of castrated subjects in terms of serum testosterone level Baseline and Days 3, 7, and 28 Safety assessed by the incidence of adverse events up to the end of treatment. approximately for 2 years Changes in serum levels of prostate-specific antigen (PSA) over time Up to one year of the treatment