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Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

Phase 2
20 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

Two doses of ASP3550 were administered to patients with prostate cancer. The primary
efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone
suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Inclusion Criteria:

- Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all

- Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA
after having prostatectomy or radiotherapy performed with curative intention may be

- Has a serum testosterone level above 1.5 ng/mL at screening

- Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of
0 to 2

Exclusion Criteria:

- Previous or present endocrine treatment for prostate cancer. However, patients who
have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6
months and in whom prostatectomy or radiotherapy was terminated at least 6 months
preceding Screening Visit may be included

- Is being treated with a 5α-reductase inhibitor

- Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy
within 12 months

- Has concurrent or a history of severe asthma (defined as a need for daily treatment
with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment

Outcome Time Frame:

1 Year

Safety Issue:


Principal Investigator

Central Contact

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Inc


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

October 2007

Completion Date:

October 2009

Related Keywords:

  • Prostatic Neoplasms
  • ASP3550
  • Degarelix
  • Prostate cancer
  • Prostatic neoplasms
  • Neoplasms
  • Prostatic Neoplasms