Phase II Study of ASP3550 in Patients With Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568516

Enrollment

273

Registered

2007-12-06

Start date

2007-10-31

Completion date

2009-10-31

Last updated

2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

ASP3550, Degarelix, Prostate cancer, Prostatic neoplasms

Brief summary

To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Detailed description

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.

Interventions

DRUGASP3550

subcutaneous administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages * 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 included * 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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment	1 Year

Secondary

Measure	Time frame
Proportion of patients with testosterone surge	1 Year
Percentage change in serum PSA	1 Year
Changes in serum levels of testosterone, LH, FSH and PSA over time	1 Year
Time to the recurrence of serum PSA	1 Year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026