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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964170
• Other study ID #: 3550-CL-0010
• Status: Completed
• Phase: Phase 3
• Start date: August 13, 2013
• Est. completion date: August 8, 2016

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: August 8, 2016
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 5a-reductase inhibitors.

• Received a 5a-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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• degarelix
subcutaneous
• Goserelin
subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   Link to results on the Astellas Clinical Study Results website