Clinical trial NCT01964170: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: ASP3550
Prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 234
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative castration rate of treatment in terms of serum testosterone level
timeFrame: Up to one year of the treatment
Secondary outcomes:
measure: Proportion of castrated subjects in terms of serum testosterone level
timeFrame: Up to one year of the treatment
measure: Proportion of castrated subjects in terms of serum testosterone level
timeFrame: Baseline and Days 3, 7, and 28
measure: Changes in serum levels of prostate-specific antigen (PSA) over time
timeFrame: Up to one year of the treatment
measure: Safety assessed by the incidence of adverse events
timeFrame: up to the end of treatment. approximately for 2 years
Other outcomes:
Locations:
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
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.