UMIN-CTR Clinical Trial

Public title

Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device and magnetic cationic liposome in prostate cancer resistant to standard treatment

Acronym

Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device

Scientific Title

Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device and magnetic cationic liposome in prostate cancer resistant to standard treatment

Scientific Title:Acronym

Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device

Region

Japan

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This phase one study aim to evaluate the safety of regional hyperthermia combined with magnetite in prostate cancer patients which resistant to standard therapy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Frequencies of adverse events grade 3 or more of CTCAE v4.0
Adverse events are evaluated at just after, 12 hours later, 24 hours later, one week later and on month later of injection of magnetite

Key secondary outcomes

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

injection of magnetite
30 mg of iron is contained by 1 ml of magnetite. Magnetite is injectied by 0.5ml into each four point of prostate.
Magnetite is injected into prostate only once before warming with RF-8

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

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male

Key inclusion criteria

All patients had a histologically confirmed daignosis of prostate cancer
Patients charactaristics. The treatment for prostate cancer is medication or radiation, not radical prostatectomy. The presence or absence of distant metastasis are not matter. Demonstrated evidence of recurrent prostatic cancer refractory to standard hormonal and anti cancer agnet therapy, including one or more hormonal drug, docetaxel, was required. Other eligibility criteria included the following: age over 20, under 80 years; Eastern Cooperative Oncology Group (EOCGI) performance status 0 to 2;

Key exclusion criteria

Exclusion criteria included the following: the patients who received radical prostatectomy; Case with metal reacting to the magnetic field in the body
(Pacemaker, implant denture, iron clip bolt); patients with pleural effusion, ascitic fluid, the pericardial effusion which need urgent treatment; patients with active infection; patients with the multiple primary cancer with less than five years in disease-free interval; patients who communication is not possible; patients who is not suitable for local anesthesia; patients who has circulatory; during anticoagulation; patients of the diabetes mellitus inadequate control; the case that a chief physician judged to be unsuitable for subject of this study

Target sample size

3

Name of lead principal investigator

1st name
Middle name
Last name	Noriyasu Kawai

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan

TEL

052-853-8266

Email

n-kawai@med.nagoya-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyasu Kawai

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan

TEL

052-853-8266

Homepage URL

Email

n-kawai@med.nagoya-cu.ac.jp

Institute

Nagoya City University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2016

Year

02

Month

24

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

2014

Year

06

Month

20

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

24

Day

Last modified on

2016

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024431