NCT00568516CompletedPhase 2
Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 273
- Primary Endpoint
- Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Study Overview
Brief Summary
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
Detailed Description
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
- •Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
- •Has a serum testosterone level above 1.5 ng/mL at screening
- •Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
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 preceding Screening Visit may be included
- •Is being treated with a 5α-reductase inhibitor
- •Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- •Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Arms & Interventions
1.Low dose group
Experimental
Intervention: ASP3550 (Drug)
2.High dose group
Experimental
Intervention: ASP3550 (Drug)
Outcomes
Primary Outcomes
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Time Frame: 1 Year
Secondary Outcomes
- Changes in serum levels of testosterone, LH, FSH and PSA over time(1 Year)
- Proportion of patients with testosterone surge(1 Year)
- Time to the recurrence of serum PSA(1 Year)
- Percentage change in serum PSA(1 Year)
Investigators
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