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Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -

Phase 2
20 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -

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

Inclusion Criteria:

- Histologically proven prostate cancer (adenocarcinoma) of all stages

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

- Serum testosterone level above 2.2 ng/mL

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

- Serum PSA level above 2 ng/mL

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

- Treated with a 5α-reductase inhibitor

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

- Concurrent or a history of severe liver disease

- Abnormal ECG such as long QTc

- A patient receiving ASP3550 in past times

- Administered drug in another clinical study or a post-market clinical study in the 28
days prior to the study

Type of Study:


Study Design:

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

Outcome Measure:

Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time

Outcome Time Frame:

Baseline and for one year

Safety Issue:


Principal Investigator

Use Central Contact

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Inc


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

October 2010

Completion Date:

July 2012

Related Keywords:

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