A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2016-08-08
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Goserelin

Criteria

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.