Phase II Study of ASP3550 in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00568516
First received: December 5, 2007
Last updated: November 10, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Drug: ASP3550
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with testosterone surge [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Percentage change in serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Changes in serum levels of testosterone, LH, FSH and PSA over time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Time to the recurrence of serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 273
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.Low dose group Drug: ASP3550
subcutaneous administration
Other Name: Degarelix
Experimental: 2.High dose group Drug: ASP3550
subcutaneous administration
Other Name: Degarelix

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568516

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shikoku, Japan
Tohoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00568516     History of Changes
Other Study ID Numbers: 3550-CL-0003
Study First Received: December 5, 2007
Last Updated: November 10, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP3550
Degarelix
Prostate cancer
Prostatic neoplasms

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

ClinicalTrials.gov processed this record on August 28, 2014