Prostate cancer
Conditions
Interventions
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
Sponsors
Jikei University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalization of serum testosterone levels (>50 ng/dL) after neoadjuvant ADT | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKenta Miki
Jikei University School of Medicine Department of Urology
Outcome results
None listed