Clinical trial NCT01261572: Study to Find Maintenance Dose for Periodic Administration of ASP3550
Official title: ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostatic neoplasms
Degarelix
ASP3550
Prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 155
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 safety and pharmacokinetics of ASP3550 will be investigated.

Eligibility criteria: 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

Primary outcomes:
measure: Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
timeFrame: Baseline and for one year
Secondary outcomes:
measure: Changes in serum level of testosterone over time
timeFrame: Baseline and for one year
measure: Changes in serum level of Luteinizing Hormone (LH) over time
timeFrame: Baseline and for one year
measure: Changes in serum level of Follicle Stimulating Hormone (FSH) over time
timeFrame: Baseline and for one year
measure: Changes in serum level of Prostate Specific Antigen (PSA) over time
timeFrame: Baseline and for one year
measure: Time to the recurrence of serum PSA
timeFrame: For one year
measure: Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
timeFrame: One year
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shiku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: