Study to Find Maintenance Dose for Periodic Administration of ASP3550

• Status: Completed
• Trial end date: 2012-04-24
• Target enrollment: 0
• Participant gender: Male

Summary

To find effective doses 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:

• 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