Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
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.
Age
20–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Phase II Study of ASP3550 in Patients With Prostate Cancer
