Phase II Study of ASP3550 in Patients With Prostate Cancer - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00568516

Purpose

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

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: ASP3550	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of ASP3550 - A Maintenance-Dose Finding Study in Patients With Prostate Cancer

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with testosterone surge [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Percentage change in serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Changes in serum levels of testosterone, LH, FSH and PSA over time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Time to the recurrence of serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment:	273
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low dose group	Drug: ASP3550 subcutaneous administration
2: Experimental High dose group	Drug: ASP3550 subcutaneous administration

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568516

Locations

Japan

Hokkaido, Japan

Tohoku, Japan

Kanto, Japan

Chubu, Japan

Kyusyu, Japan

Chugoku, Japan

Shikoku, Japan

Kansai, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc ( Director )
Study ID Numbers:	3550-CL-0003
Study First Received:	December 5, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00568516
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

ASP3550
Degarelix
Prostate cancer
Prostatic neoplasms

Study placed in the following topic categories:

Signs and Symptoms
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009