Status:
COMPLETED
Study to Find Maintenance Dose for Periodic Administration of ASP3550
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
20+ years
Phase:
PHASE2
Brief Summary
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Detailed 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 saf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01261572
Start Date
October 12 2010
End Date
April 24 2012
Last Update
October 31 2024
Active Locations (8)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan