A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer
Not Applicable
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000015519
- Lead Sponsor
- Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
1) Have previously received hormonal therapies including GnRH agonists, GnRH antagonists, and antiandrogen agents, estorogen agents or orchiectomy for PCa 2) Be using 5alpha reductase inhibitor 3) Have severe asthma (e.g. use inhaled corticosteroid that is necessary for daily life), anaphylactic reaction, severe urticaria and complication or medical history of angioedema 4) Be sensitive to mannitol 5) Have multiple malignancies 6) Have ALT>= 100 IU/L or total bilirubin >= 1.3 mg/dL 7) Be considered as inappropriate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ormalization of serum testosterone levels (>50 ng/dL) after neoadjuvant ADT
- Secondary Outcome Measures
Name Time Method 1) The percent reduction in TPV during neoadjuvant ADT 2) The percent increase of TPV after 125I-TPPB 3) The improvement of QOL using the IPSS for lower urinary tract symptoms 4) The proportion of patients who have serum testosterone levels over 50 ng/dL at 12 weeks after 125I-TPPB 5) The improvement of QO