Study to Find Maintenance Dose for Periodic Administration of ASP3550

Astellas

Status and phase

Completed

Phase 2

Conditions

Prostatic Neoplasms

Treatments

Drug: degarelix

Study type

Interventional

Funder types

Industry

Identifiers

NCT01261572

3550-CL-0009

Details and patient eligibility

About

To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

Full description

ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Enrollment

155 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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