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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-13

Study Completion Date

2016-08-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP3550 PART 1 and PART 2

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

Group Type EXPERIMENTAL

degarelix

Intervention Type DRUG

subcutaneous

Goserelin

part 1 for 1 year treatment

Group Type ACTIVE_COMPARATOR

Goserelin

Intervention Type DRUG

subcutaneous

Interventions

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degarelix

subcutaneous

Intervention Type DRUG

Goserelin

subcutaneous

Intervention Type DRUG

Other Intervention Names

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ASP3550

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No