Clinical trial · Interventional
Phase II Study of ASP3550 in Patients With Prostate Cancer
Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
NCT00568516CI-TRIAL-00015934completedPhase 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 assess the effect 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 |
|---|---|---|---|
| ASP3550 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1.Low dose group
- interventionNames
- Drug: ASP3550
- type
- EXPERIMENTAL
- label
- 2.High dose group
- interventionNames
- Drug: ASP3550
Primary outcomes (1)
- measure
- Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
- timeFrame
- 1 Year
Secondary outcomes (4)
- measure
- Proportion of patients with testosterone surge
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.