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Completed

NCT Number: NCT01261572

Study to Find Maintenance Dose for Periodic Administration of ASP3550

To find effective doses 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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 2
  • 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

Treatment and study plan

degarelix

Drug

periodic injection

Other names: ASP3550

Primary outcomes

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

    Time frame: Baseline and for one year

Secondary outcomes

  1. Changes in serum level of testosterone over time

    Time frame: Baseline and for one year

  2. Changes in serum level of Luteinizing Hormone (LH) over time

    Time frame: Baseline and for one year

  3. Changes in serum level of Follicle Stimulating Hormone (FSH) over time

    Time frame: Baseline and for one year

  4. Changes in serum level of Prostate Specific Antigen (PSA) over time

    Time frame: Baseline and for one year

  5. Time to the recurrence of serum PSA

    Time frame: For one year

  6. Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2010
Registry last updated
Oct 31, 2024

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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