A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

May 31, 2019 updated by: Astellas Pharma Inc

ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -

To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer.

The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 3

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
      • Kyushu, Japan
      • Shikoku, 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

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patient with histologically confirmed prostate cancer (adenocarcinoma).
  • Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included.
  • Has a serum testosterone level above 2.2 ng/mL at screening.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening.
  • Has a serum PSA ≥ 2 ng/mL at screening.
  • Has a life expectancy of at least 12 months.

Exclusion Criteria:

  • Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors.
  • Received a 5α-reductase inhibitor within 25 weeks preceding screening.
  • Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months.
  • Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema.
  • Has hypersensitivity towards mannitol.
  • Has a marked prolongation of QT/QTc interval (two consecutive increases to >450 ms in QTc interval at retest) at screening.
  • Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASP3550 PART 1 and PART 2
Part 1 for 1 year treatment and Part 2 for an extended period of treatment
Drug: degarelix
subcutaneous
Other Names:
  • ASP3550
Active Comparator: Goserelin
part 1 for 1 year treatment
Drug: Goserelin
subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative castration rate of treatment in terms of serum testosterone level
Time Frame: Up to one year of the treatment
Up to one year of the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of castrated subjects in terms of serum testosterone level
Time Frame: Up to one year of the treatment
Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Time Frame: Baseline and Days 3, 7, and 28
Baseline and Days 3, 7, and 28
Changes in serum levels of prostate-specific antigen (PSA) over time
Time Frame: Up to one year of the treatment
Up to one year of the treatment
Safety assessed by the incidence of adverse events
Time Frame: up to the end of treatment. approximately for 2 years
up to the end of treatment. approximately for 2 years

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.

General Publications

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)

August 13, 2013

Primary Completion (Actual)

June 5, 2015

Study Completion (Actual)

August 8, 2016

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3550-CL-0010

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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

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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