Prospective study of prevention of recurrence of prostate cancer with bone metastasis and prevention of bone mineral density decrease by combination therapy with hormonal therapy and zoledronic acid

Prospective study of prevention of recurrence of prostate cancer with bone metastasis and prevention of bone mineral density decrease by combination therapy with hormonal therapy and zoledronic acid - Combination of zoledronic acid and hormonal therapy for prostate cancer with bone metastasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001137

Enrollment

100

Registered

2010-05-20

Start date

2006-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

hormonal therapy hormonal therapy and zoledronic acid

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: We have to satisfy all the following basis. 1)The case that an agreement is obtained in a document about participation of the final examination 2)The case that it is diagnosed as prostate cancer pathologically, and have bone metastasis in bone scintigraphy clearly 3)A case of non-therapy prostate cancer. But we are possible after hormonal therapy initiation for less than 1 month. 4)Case general condition myelic function is maintained a heart / liver / a kidney enough and to satisfy the next condition: (a) performance status:0-3 (b) WBC: more than 3,000/mm3 (c) Platelet: more than 100,000/mm3 (d) Hb: more than 9 mg/dL (e) serum ALT (GPT) equal to or less than 3.0 times of institution upper limits of normal (f)BUN eLess than 30mg/dL equal to or less than 3.0 times of institution upper limits of normal (g)Less than serum creatinine 3.0mg/dL (h) Ca:8.5-11.5mg/dL

Exclusion criteria

Exclusion criteria: 1) The person whom we gave bisphosphonate before beginning of dosage 2)The person who performed bone radiotherapy within beginning of dosage three months 3)serum correction Ca value less than 8.0 mg or active cancer except equal or more than 11.6 mg 4)serum creatinine:more than 3.0mg / dL 5) Active cancer except prostate cancer is the patient in less than 3 years 6)The patient having a grave complication 7)In addition, the patient whom we intended for it, and it was judged judgment of a doctor to be inadequate 8)The case that does not fall under criteria for selection of nine case) subject cases with a plan to perform invasive dentist treatment 9)Bisphosphonate, it is a case with anaphylactic medical history

Design outcomes

Primary

Measure	Time frame
recurrence free survival, survival time, survival rate	—

Secondary

Measure	Time frame
bone mineral density	—

Countries

Japan

Contacts

Public ContactAtsushi Mizokami

Kanazawa University Urology

mizokami@med.kanazawa-u.ac.jp076-265-2393

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026