DRUG
degarelix
subcutaneous
Status
Completed
Phase
Phase 3
Enrollment
234
Locations
8
Results
Not posted
Publications
2
Study summary
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
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.
Interventions
DRUG
subcutaneous
DRUG
subcutaneous
Timeline
First posted
Oct 17, 2013
Study start
Aug 13, 2013
Primary completion
Jun 5, 2015
Study completion
Aug 8, 2016
Results posted
Not reported
Registry updated
Oct 31, 2024
Outcomes
Cumulative castration rate of treatment in terms of serum testosterone level
Time frame · Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Time frame · Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Time frame · Baseline and Days 3, 7, and 28
Changes in serum levels of prostate-specific antigen (PSA) over time
Time frame · Up to one year of the treatment
Safety assessed by the incidence of adverse events
Time frame · up to the end of treatment. approximately for 2 years
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 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.
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Chugoku, Japan
Facility not named
Chūbu, Japan
Facility not named
Hokkaido, Japan
Facility not named
Kansai, Japan
Facility not named
Kantou, Japan
Facility not named
Kyushu, Japan
Facility not named
Shikoku, Japan
Facility not named
Tōhoku, Japan
Publications
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