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Completed

NCT Number: NCT00568516

Phase II Study of ASP3550 in Patients With Prostate Cancer

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

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Chugoku, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP3550

Drug

subcutaneous administration

Other names: Degarelix

Primary outcomes

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

    Time frame: 1 Year

Secondary outcomes

  1. Proportion of patients with testosterone surge

    Time frame: 1 Year

  2. Percentage change in serum PSA

    Time frame: 1 Year

  3. Changes in serum levels of testosterone, LH, FSH and PSA over time

    Time frame: 1 Year

  4. Time to the recurrence of serum PSA

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 6, 2007
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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