Phase II Study of ASP3550 in Patients With Prostate Cancer

October 28, 2014 updated by: Astellas Pharma Inc

Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was 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)

273

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
      • Kanto, Japan
      • Kyusyu, Japan
      • Shikoku, Japan
      • Tohoku, 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

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
  • Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
  • Has a serum testosterone level above 1.5 ng/mL at screening
  • Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2

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 preceding Screening Visit may be included
  • Is being treated with a 5α-reductase inhibitor
  • Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
  • Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

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: 1.Low dose group
Drug: ASP3550
subcutaneous administration
Other Names:
  • Degarelix
Experimental: 2.High dose group
Drug: ASP3550
subcutaneous administration
Other Names:
  • Degarelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Time Frame: 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with testosterone surge
Time Frame: 1 Year
1 Year
Percentage change in serum PSA
Time Frame: 1 Year
1 Year
Changes in serum levels of testosterone, LH, FSH and PSA over time
Time Frame: 1 Year
1 Year
Time to the recurrence of serum PSA
Time Frame: 1 Year
1 Year

Collaborators and Investigators

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

Sponsor

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

October 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3550-CL-0003

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.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on ASP3550

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe