Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.

Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients. - Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002577

Enrollment

Registered

2009-10-05

Start date

2009-12-01

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

MAB (combination of LHRH agonist and non-steroidal antiandrogen) therapy until PSA refractory MAB therapy with 4mg Zoledronic acid at every 4 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Untreated prostate cancer patients with bone metastasis 2. Age is 85 years old or less. 3. Keeping liver and kidney function and filled following criteria; * WBC: >= 3000 / mm3 * PLT: >= 10,000 / mm3 * Ht: <= normal range * AST(GOT): <= 2.5 times high end of the normal range * ALT(GPT): <= 2.5 times high end of the normal range * GGT: <= 2.5 times high end of the normal range * ALP: <= 2.5 times high end of the normal range * LDH: <= 1.5 times high end of the normal range * sCr: <= 3.0 times high end of the normal range * Performance Status(ECOG) 0,1 (including seeming PS 2-4 by only bone metastasis) * agreement of participation from patients by document with sufficient explanation

Exclusion criteria

Exclusion criteria: 1.CCr < 30mL/min by calculation of Codkcroft Gault equation. 2. Another cancer that requires treatment 3. Patients coexisting psychiatric disease or neurological symptom 4. Patients with continuous systematic treatment with steroids 5. Participation in the present study is considered inappropriate by a Clinical Investigator

Design outcomes

Primary

Measure	Time frame
1 PSA nadir rate 2 Time to PSA nadir	—

Secondary

Measure	Time frame
1 Refractory Free Survival 2 Safety	—

Countries

Japan

Contacts

Public ContactKen Nakagawa

Keio University School of Medicine Department of Urology

mizunor@z7.keio.jp03-5363-3825

Outcome results

None listed

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