Unique ID issued by UMIN | UMIN000015519 |
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Receipt number | R000018030 |
Scientific Title | 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 |
Date of disclosure of the study information | 2014/11/04 |
Last modified on | 2019/02/12 11:42:06 |
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
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
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
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
Japan |
Prostate cancer
Urology |
Malignancy
NO
To compare the efficacy between GnRH antagonist, degarelix, and GnRH agonists on the recovery of serum testosterone levels and reduction in total prostate volume (TPV) in neoadjuvant androgen deprivation therapy (ADT) for patient with PCa undergoing 125I-transperineal prostate brachytherapy (TPPB).
Safety,Efficacy
Normalization of serum testosterone levels (>50 ng/dL) after neoadjuvant ADT
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 QOL
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
The initial dose of degarelix is 240 mg given as 2 subcutaneous injections of 120 mg in the abdomen. After the initial dose, the maintenance dose of 80 mg is given as one subcutaneous injection in the abdomen every 4 weeks.
Leuprorelin acetate is administered subcutaneously once every 4 weeks at a dose of 3.75 mg, or goserelin acetate is administered subcutaneously in the abdomen once every 4 weeks at a dose of 3.6 mg.
20 | years-old | <= |
Not applicable |
Male
1) Be a definitive histological diagnosis of PCa by needle biopsy
2) Be adaptable to 125I-TPPB and requred for neoadjuvant ADT
3) Have low/intermediate-risk localized PCa as follows.
Low-risk PCa: cT1a-T2a, Gleason score: 2-6 and PSA<10 ng/ml
Intermediate-risk PCa: cT2b -T2c or Gleason score: 7, or PSA 10-20 ng/ml
(exept for Gleason score>=8, PSA>=20 ng/ml)
4) TPV: 35-60 ml
5) Recieved written informed consent prior to initiating this clinical study
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
56
1st name | |
Middle name | |
Last name | Kenta Miki |
Jikei University School of Medicine
Department of Urology
3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Japan
03-3433-1111
kentamiki@jikei.ac.jp
1st name | |
Middle name | |
Last name | Kenta Miki |
Jikei University School of Medicine
Department of Urology
3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Japan
03-3433-1111
kentamiki@jikei.ac.jp
Jikei University School of Medicine
Astellas Pharma Inc.
Profit organization
Translational Research Informatics Center (Foundation for Biomedical Research and Innovation)
NO
2014 | Year | 11 | Month | 04 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 02 | Day |
2014 | Year | 12 | Month | 01 | Day |
2014 | Year | 10 | Month | 24 | Day |
2019 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018030
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