Phase II Study of ASP3550 in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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