Clinical trial · Interventional
Study to Find Maintenance Dose for Periodic Administration of ASP3550
ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
NCT01261572CI-TRIAL-00082108completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High dose group
- description
- ASP3350 high dose
- interventionNames
- Drug: degarelix
- type
- EXPERIMENTAL
- label
- Low dose group
- description
- ASP3350 low dose
- interventionNames
- Drug: degarelix
Primary outcomes (1)
- measure
- Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
- timeFrame
- Baseline and for one year
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.