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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

degarelix

Goserelin

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring ASP3550, Prostate cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASP3550 PART 1 and PART 2

Goserelin

Arm Description

Part 1 for 1 year treatment and Part 2 for an extended period of treatment

part 1 for 1 year treatment

Outcomes

Primary Outcome Measures

Cumulative castration rate of treatment in terms of serum testosterone level

Secondary Outcome Measures

Proportion of castrated subjects in terms of serum testosterone level

Changes in serum levels of prostate-specific antigen (PSA) over time

Safety assessed by the incidence of adverse events

Full Information

NCT ID

NCT01964170

First Posted

October 15, 2013

Last Updated

May 31, 2019

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01964170

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

August 13, 2013 (Actual)

Primary Completion Date

June 5, 2015 (Actual)

Study Completion Date

August 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

ASP3550, Prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

234 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP3550 PART 1 and PART 2

Arm Type

Experimental

Arm Description

Part 1 for 1 year treatment and Part 2 for an extended period of treatment

Arm Title

Goserelin

Arm Type

Active Comparator

Arm Description

part 1 for 1 year treatment

Intervention Type

Drug

Intervention Name(s)

degarelix

Other Intervention Name(s)

ASP3550

Intervention Description

subcutaneous

Intervention Type

Drug

Intervention Name(s)

Goserelin

Intervention Description

subcutaneous

Primary Outcome Measure Information:

Title

Cumulative castration rate of treatment in terms of serum testosterone level

Time Frame

Up to one year of the treatment

Secondary Outcome Measure Information:

Title

Proportion of castrated subjects in terms of serum testosterone level

Time Frame

Up to one year of the treatment

Title

Proportion of castrated subjects in terms of serum testosterone level

Time Frame

Baseline and Days 3, 7, and 28

Title

Changes in serum levels of prostate-specific antigen (PSA) over time

Time Frame

Up to one year of the treatment

Title

Safety assessed by the incidence of adverse events

Time Frame

up to the end of treatment. approximately for 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Principal Investigator

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kantou

Country

Japan

City

Kyushu

Country

Japan

City

Shikoku

Country

Japan

City

Touhoku

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

34350976

Citation

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.

Results Reference

derived

PubMed Identifier

29624800

Citation

Ozono 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.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=310

Description

Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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