Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01964170
Collaborator
(none)
234
Enrollment
8
Locations
2
Arms
35.8
Actual Duration (Months)
29.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
Actual Study Start Date :
Aug 13, 2013
Actual Primary Completion Date :
Jun 5, 2015
Actual Study Completion Date :
Aug 8, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative castration rate of treatment in terms of serum testosterone level [Up to one year of the treatment]

    Secondary Outcome Measures

    1. Proportion of castrated subjects in terms of serum testosterone level [Up to one year of the treatment]

    2. Proportion of castrated subjects in terms of serum testosterone level [Baseline and Days 3, 7, and 28]

    3. Changes in serum levels of prostate-specific antigen (PSA) over time [Up to one year of the treatment]

    4. Safety assessed by the incidence of adverse events [up to the end of treatment. approximately for 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chubu Japan
    2 Chugoku Japan
    3 Hokkaido Japan
    4 Kansai Japan
    5 Kantou Japan
    6 Kyushu Japan
    7 Shikoku Japan
    8 Touhoku Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Principal Investigator: Medical Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01964170
    Other Study ID Numbers:
    • 3550-CL-0010
    First Posted:
    Oct 17, 2013
    Last Update Posted:
    Jun 4, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Inc
    ASP3550
    Prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Goserelin

    Study Results

    No Results Posted as of Jun 4, 2019