UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device and magnetic cationic liposome in prostate cancer resistant to standard treatment
Title of the study (Brief title)	Phase one clinical trials of hyperthermia using radiofrequency capacitive heating device
Region	Japan

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

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	Noriyasu Kawai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan
TEL	052-853-8266
Email	n-kawai@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Noriyasu Kawai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan
TEL	052-853-8266
Homepage URL
Email	n-kawai@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2016 Year 02 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 20 Day
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

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

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2016 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024431