UMIN-CTR Clinical Trial

Public title

A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.

Acronym

CRPC with BM/ZOL-CTC Study

Scientific Title

A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.

Scientific Title:Acronym

CRPC with BM/ZOL-CTC Study

Region

Japan

Condition

Castration resistant prostate cancer

Classification by specialty

Hematology and clinical oncology

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

It is the aim of this prospective, single arm, open-label clinical study to investigate the effect of zoledronic acid given every 4 weeks for 3 months on circulating tumor cells in patients with castration resistant prostate cancer with bone metastases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid

Key secondary outcomes

*Relationship between PSA and course of CTCs
*Proportion of patients with stable or decreased CTCs at 12 weeks
*Proportion of patients with stable CTCs at 12 weeks
*Analysis of patients based on baseline CTCs (Proportion of patients with stable or decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with stable or decreased CTCs below 5 CTCs at baseline)
*Analysis of patients based on baseline CTCs (Proportion of patients with decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with decreased CTCs below 5 CTCs at baseline)
*Time until decrease of CTCs
*Safety and Tolerability (adverse events, serious adverse events )

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

All patients will be treated with zoledronic acid (dosage according to calculated creatinine clearance before first administration of zoledronic acid) administered as a 15-minute infusion every 4 weeks for 3 months.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1) Histologically proven carcinoma of the prostate with evidence of at least one cancer related bone lesion with castration resistant prostate cancer (2 or more consecutive rising PSA values determined in 2 or more weeks interval).
2) No changes in antitumoral treatment planned through the course of study.
3) Prior surgery, chemotherapy and radiotherapy of metastases (including therapeutic radioisotopes such as strontium 89) is allowed. At least 2 months must have elapsed after completion of surgery, chemotherapy and radiotherapy.
4) Patients with presence of CTCs
5) Performance status ECOG 0-2
6) Laboratory requirements:
a) hepatic function: total bilirubin less than 2,5 times the upper-normal limit of the institution, b) AST, ALT less than 2,5 times the upper-normal limit of the institution.
c) Renal function: creatinine clearance more than 30 ml/min
Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= [140-age (years)] x weight (kg) }
[72 x serum creatinine (mg/dL)]
7) Life expectancy more than 6 months
8) Signed informed consent prior to trial entry

Key exclusion criteria

1) Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid
2) Prior treatment with antiresorptive agent (e.g. RANK ligand inhibitor)
3) Patients with proven brain metastases
4) History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
5) Patients with need of treatment for osteoporosis (defined according to DXA, lumber spine BMD T-Score less than 2.5).
6) Patients with NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG
7) Patients with clinically significant ascites
8) Known hypersensitivity to zoledronic acid or other bisphosphonates
9) Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl) or more than 12.0 mg/dl
10) Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more than 5 yrs.
11) Current active dental problems including infection of the teeth or jawbone
12) Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
13) Any change in therapy within the last 2 months (Chemotherapy, change in hormonal therapy)
14) Known history or present abuse of alcohol or drugs
15) Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Shigeo Horie, M.D.

Organization

Teikyo University, School of Medicine

Division name

Department of Urology

Zip code

Address

2-11-1, Kaga, Itabashi-ku, Tokyo, Japan, 173-8605

TEL

03-3964-2497

Email

Name of contact person

1st name
Middle name
Last name	Hisamitsu Ide, M.D.

Organization

Teikyo University, School of Medicine

Division name

Department of Urology

Zip code

Address

2-11-1, Kaga, Itabashi-ku, Tokyo, Japan, 173-8605

TEL

03-3964-2497

Homepage URL

Email

hisamit@med.teikyo-u.ac.jp

Institute

Teikyo University, School of Medicine
Department of Urology

Institute

Department

Personal name

Organization

Novartis Pharma K.K

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

杏林大学病院（東京都）、慶應義塾大学病院(東京都）、札幌医科大学病院（北海道）、日本医科大学病院(東京都）、昭和大学病院(東京都）、がん研有明病院（東京都）、獨協医科大学越谷病院(埼玉県）

Date of disclosure of the study information

2011

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2014

Year

03

Month

31

Day

Date of closure to data entry

2014

Year

10

Month

31

Day

Date trial data considered complete

2014

Year

12

Month

31

Day

Date analysis concluded

2015

Year

03

Month

01

Day

Other related information

Registered date

2011

Year

11

Month

16

Day

Last modified on

2014

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007926