Urological Cancer with bone metastasis (Hormone resistant prostate cancer, Kidney cancer, urothelial cancer, kidney pelvis and ureteral cancer)
Conditions
Interventions
4mg Zoledronic Acid will be administered every 4 weeks for 96 weeks(24 times)
Sponsors
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Kyushu Univ UOEH Harasanshin Hospital Kurume Univ Saga Univ Nagasaki Univ Nagasaki Municipal Hospital Nagasaki Genbaku Hospital Oita Univ Miyazaki Univ Kagoshima Univ Ryukyu Univ Hokkaido Univ Nagasaki Med. Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Hormone resistant prostate cancer, renal cell cancer, or urothelial cancer (bladder cancer, renal pelvic and ureteral cancer) patients with bone metastasis diagnosed clinically and pathologically. 2. PS 0-2(ECOG) (include PS 3,4 by bone metastasis) 3. Age: >= 20 years old ;< 85 years old 4. Keeping organ function 5. Taking agreement by document regarding participation for this clinical study
Exclusion criteria
Exclusion criteria: 1.Experience of bisphosphonate administration (orally or iv) 2.Experience of radiation therapy to bone lesion within 3 months. 3.Experience of 89Sr injection 4.Patients suffering from Renal failure 5.Secnod cancer except above target urological cancer 6.Planned invasive dental therapy and under invasive dental therapy 7.Femail during pregnancy or with possible pregnancy. Female during lactation 8.Coexsistence with mental disorder or neurological symptom 9.disqualified by a medical doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Skeletal Related Events (SRE) incidence during study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.SRE free survival 2.Change of bone-marker(urinary NTx, serum BAP, serum I-CTP) 3.Frequency of adverse events 4.Change of QOL score 5. Bone specific progression free survival 6.Change of BMD 7.Prastate-Specific Antigen (PSA) specific progression free survival 8.Overall survival | — |
Countries
Japan
Contacts
Public ContactAkira Yokomizo
Graduate School of Medical Sciences, Kyushu University Department of Urology
Outcome results
None listed