NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prostate Cancer
Date of first enrollment	28/12/2009
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TAK-448 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Subcutaneous administration

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Male
Include criteria	1. The subject is a Japanese male who was histopathologically confirmed the diagnosis of prostate cancer 2. The subject is confirmed to have neither lymphatic nor distant metastasis on imaging diagnosis within 4 weeks (28 days) prior to enrollment 3. The subject is considered eligible for receiving hormonotherapy as treatment for prostate cancer 4. The subject has ECOG Performance Status (PS) of 0 to 1 at the time of enrollment 5. The subject has no history of hormonotherapy [gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, steroidal anti-androgenic agent, non-steroidal anti-androgenic agent, etc] or chemotherapy for prostate cancer prior to the first dose of study medication 6. The subject has not received surgical castration 8. The subject's serum testosterone level within 2 weeks (14 days) prior to enrollment is higher than the lower limit of the standard value of each site 9. The subject's serum PSA within 2 weeks (14 days) prior to enrollment meets the following standards: For subjects with previously untreated prostate cancer: 4.0 ng/mL or higher For subjects with previously treated prostate cancer*: 0.2 ng/mL or higher *: Subjects who have received radiotherapy (except 125I seed implants brachytherapy), prostatectomy, or high intensity focused ultrasound, or all three prior to the start of the study. etc.
Exclude criteria	1. The subject has received 125I seed implants brachytherapy 2. The subject has received any of the following treatment within 16 weeks (112 days) prior to enrollment: 1) Radiation therapy (except 125I seed implants brachytherapy) 2) Prostatectomy 3) High intensity focused ultrasound 3. The subject has active multiple primary cancers (synchronous multiple primary cancer and metachronous multiple primary cancer with the disease-free survival = > 5 years) 4. The subject has poorly controlled hypertension 5. The subject has poorly controlled diabetes 6. The subject has ischemic heart disease requiring treatment 7. The subject has interstitial pneumonia or is suspected to have interstitial pneumonia 8. The subject has had myocardial infarction within 26 weeks (182 days) prior to enrollment 9. The subject has a history of cerebral infarction (including transient ischemic attack) except for lacunar infarction 10. The subject has had surgeries within 12 weeks (84 days) prior to the Entry (excluding local surgeries such as cataract surgery and exploratory biopsy of prostate. For prostatectomy, see Exclusion Criteria 2) 11. The subject has used adrenal corticosteroids (excluding external drugs) within 14 days prior to the first dose of study medication 12. The subject has used androgens or supplements containing saw palmetto within 14 days prior to the first dose of study medication etc.