Study to Find Maintenance Dose for Periodic Administration of ASP3550

Prostatic Neoplasms Clinical Trial

Official title:

ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261572
• Other study ID #: 3550-CL-0009
• Status: Completed
• Phase: Phase 2
• Start date: October 12, 2010
• Est. completion date: April 24, 2012

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 24, 2012
• Est. primary completion date: April 24, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 5a-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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• degarelix
periodic injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of patients with serum testosterone =0.5 ng/mL over time		Baseline and for one year
Secondary	Changes in serum level of testosterone over time		Baseline and for one year
Secondary	Changes in serum level of Luteinizing Hormone (LH) over time		Baseline and for one year
Secondary	Changes in serum level of Follicle Stimulating Hormone (FSH) over time		Baseline and for one year
Secondary	Changes in serum level of Prostate Specific Antigen (PSA) over time		Baseline and for one year
Secondary	Time to the recurrence of serum PSA		For one year
Secondary	Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests		One year

External Links

•   Link to results on the Astellas Clinical Study Results website