UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Title of the study (Brief title)	Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To see additive effects of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: time to progression, SRE rate, PSA response, adverse effects, etc, comparing with historical controls without bone-modifying agents.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to progression
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	4mg zoledronic acid will be administered at three-month intervals until becoming a castration resistant prostate cancer.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key 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
Key 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.
Target sample size	100

Research contact person
Name of lead principal investigator	Satoru Kawakami
Organization	Saitama Medical Center, Saitama Medical University
Division name	Urology
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3673
Email	kawakami@saitama-med.ac.jp

Public contact
Name of contact person	Akihiro Yano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Urology
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3673
Homepage URL
Email	yanoaki@saitama-med.ac.jp

Sponsor
Institute	Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Urology, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 20 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 20 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012586