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Study to Find Maintenance Dose for Periodic Administration of ASP3550

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ClinicalTrials.gov Identifier: NCT01261572
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : July 10, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: ASP3350 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -
Study Start Date : October 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: High dose group
ASP3350 high dose
Drug: ASP3350
periodic injection
Experimental: Low dose group
ASP3350 low dose
Drug: ASP3350
periodic injection

Outcome Measures

Primary Outcome Measures :
  1. Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time [ Time Frame: Baseline and for one year ]

Secondary Outcome Measures :
  1. Changes in serum level of testosterone over time [ Time Frame: Baseline and for one year ]
  2. Changes in serum level of Luteinizing Hormone (LH) over time [ Time Frame: Baseline and for one year ]
  3. Changes in serum level of Follicle Stimulating Hormone (FSH) over time [ Time Frame: Baseline and for one year ]
  4. Changes in serum level of Prostate Specific Antigen (PSA) over time [ Time Frame: Baseline and for one year ]
  5. Time to the recurrence of serum PSA [ Time Frame: For one year ]
  6. Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261572

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shiku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01261572     History of Changes
Other Study ID Numbers: 3550-CL-0009
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013

Keywords provided by Astellas Pharma Inc:
Prostate cancer
Prostatic neoplasms

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases