Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study

Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study - Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010765

Enrollment

100

Registered

2013-05-20

Start date

2013-05-20

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

4mg zoledronic acid will be administered at three-month intervals until becoming a castration resistant prostate cancer.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Signed informed consent is obtained prior to the entry to this clinical study. 2) Patients with histologically confirmed adeno- carcinoma of the prostate. 3) Patients with radiologic evidence of bone metastasis. 4) Treatment-naive prostate cancer patients. 5) Age is >=20 years old. 6) Performance status ECOG 0~2 including performance status 3~4 accompanied by symptoms only due to bone metastasis. 7) Laboratory requirements a) WBC >=3000/mm3 or neutrophil >=1500/mm3 b) Hemoglobin >=9.0g c) Platelet >=100000/mm3 d) Total bilirubin <=1.5 times of upper limit of normal e) AST and ALT <=2.5 times of upper limit of normal f) serum Creatinine <=2.0mg/dL g) serum Calcium (adjusted) >=8.0mg/dL

Exclusion criteria

Exclusion criteria: Patients 1) do not meet the inclusion criteria. 2) have an allergy to bisphosphonates including zoledronic acid. 3) required an urgent radiation therapy for bone metastasis based on symptoms described below: unmanageable pain, spinal cord paralysis, etc. 4) have a treatment history with a bisphosphonate (excluding bisphosphonates taken orally). 5) have an uncontrollable pleural or pericardial effusion. 6) have a brain metastasis with symptoms. 7) have a heavy infection. 8) under or planned an invasive dental treatment. 9) have an interstitial pneumonitis or pulmonary fibrosis. 10) have an active cancer except prostate cancer: cancer free duration <= 3 years. 11) have a myocardial infarction within 6 months. 12) have severe complications: cardiovascular disease, hepatic dysfunction, or coagulation disorders, etc. 13) have mental disorders or neurological symptoms. 14) disqualified by a doctor in charge.

Design outcomes

Primary

Measure	Time frame
Time to progression	—

Secondary

Measure	Time frame
1) SRE rate 2) Time to the first SRE 3) PSA response 4) Changes in ALP, BAP, serum NTx, TRAP-5b 5) Adverse effects 6) Changes in bone scan index 7) Changes in bone mineral density	—

Countries

Japan

Contacts

Public ContactAkihiro Yano

Saitama Medical Center, Saitama Medical University Urology

yanoaki@saitama-med.ac.jp049-228-3673

Outcome results

None listed

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