DRUG
degarelix
periodic injection
Status
Completed
Phase
Phase 2
Enrollment
155
Locations
8
Results
Not posted
Publications
0
Study summary
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
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.
Interventions
DRUG
periodic injection
Timeline
First posted
Dec 16, 2010
Study start
Oct 12, 2010
Primary completion
Apr 24, 2012
Study completion
Apr 24, 2012
Results posted
Not reported
Registry updated
Oct 31, 2024
Outcomes
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Time frame · Baseline and for one year
Changes in serum level of testosterone over time
Time frame · Baseline and for one year
Changes in serum level of Luteinizing Hormone (LH) over time
Time frame · Baseline and for one year
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Time frame · Baseline and for one year
Changes in serum level of Prostate Specific Antigen (PSA) over time
Time frame · Baseline and for one year
Time to the recurrence of serum PSA
Time frame · For one year
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
Time frame · One year
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 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
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Chugoku, Japan
Facility not named
Chūbu, Japan
Facility not named
Hokkaido, Japan
Facility not named
Kansai, Japan
Facility not named
Kantou, Japan
Facility not named
Kyusyu, Japan
Facility not named
Shuku, Japan
Facility not named
Tōhoku, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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