A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer
ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
1 other identifier
interventional
234
1 country
8
Brief Summary
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Aug 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2016
CompletedOctober 31, 2024
October 1, 2024
1.8 years
October 15, 2013
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative castration rate of treatment in terms of serum testosterone level
Up to one year of the treatment
Secondary Outcomes (4)
Proportion of castrated subjects in terms of serum testosterone level
Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Baseline and Days 3, 7, and 28
Changes in serum levels of prostate-specific antigen (PSA) over time
Up to one year of the treatment
Safety assessed by the incidence of adverse events
up to the end of treatment. approximately for 2 years
Study Arms (2)
ASP3550 PART 1 and PART 2
EXPERIMENTALPart 1 for 1 year treatment and Part 2 for an extended period of treatment
Goserelin
ACTIVE COMPARATORpart 1 for 1 year treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
Related Publications (2)
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PMID: 34350976DERIVEDOzono S, Tsukamoto T, Naito S, Horie S, Ohashi Y, Uemura H, Yokomizo Y, Fukasawa S, Kusuoka H, Akazawa R, Saito M, Akaza H. Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study. Cancer Sci. 2018 Jun;109(6):1920-1929. doi: 10.1111/cas.13600. Epub 2018 May 23.
PMID: 29624800DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 17, 2013
Study Start
August 13, 2013
Primary Completion
June 5, 2015
Study Completion
August 8, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/.