NCT00568516

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

December 5, 2007

Last Update Submit

October 28, 2014

Conditions

Prostatic Neoplasms

Keywords

ASP3550DegarelixProstate cancerProstatic neoplasms

Outcome Measures

Primary Outcomes (1)

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

    1 Year

Secondary Outcomes (4)

  • 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

Study Arms (2)

1.Low dose group

EXPERIMENTAL
Drug: ASP3550

2.High dose group

EXPERIMENTAL
Drug: ASP3550

Interventions

ASP3550DRUG

subcutaneous administration

Also known as: Degarelix
1.Low dose group2.High dose group

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

JP(8)