Study to Find Maintenance Dose for Periodic Administration of ASP3550

October 29, 2024 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyusyu, Japan
      • Shiku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose group
ASP3350 high dose
Drug: degarelix
periodic injection
Other Names:
  • ASP3550
Experimental: Low dose group
ASP3350 low dose
Drug: degarelix
periodic injection
Other Names:
  • ASP3550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Time Frame: Baseline and for one year
Baseline and for one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in serum level of testosterone over time
Time Frame: Baseline and for one year
Baseline and for one year
Changes in serum level of Luteinizing Hormone (LH) over time
Time Frame: Baseline and for one year
Baseline and for one year
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Time Frame: Baseline and for one year
Baseline and for one year
Changes in serum level of Prostate Specific Antigen (PSA) over time
Time Frame: Baseline and for one year
Baseline and for one year
Time to the recurrence of serum PSA
Time Frame: For one year
For one year
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Chair: Use Central Contact, Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2010

Primary Completion (Actual)

April 24, 2012

Study Completion (Actual)

April 24, 2012

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimated)

December 16, 2010

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3550-CL-0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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