Phase II Study of ASP3550 in Patients With Prostate Cancer

Astellas

Status and phase

Completed

Phase 2

Conditions

Prostatic Neoplasms

Treatments

Drug: ASP3550

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568516

3550-CL-0003

Details and patient eligibility

About

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

Full 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.

Enrollment

273 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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