UMIN-CTR Clinical Trial

Public title

The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.

Acronym

The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.

Scientific Title

The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.

Scientific Title:Acronym

The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.

Region

Japan

Condition

Prostate cancer

Classification by specialty

Urology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the relapse-free survival rate of the patients who received the focal brachytherapy prospectively.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

biochemical relapse-free survival rates by using the Phoenix definition
Clinical relapse-free survival rates by using the imaging evaluation by the magnetic resonance imaging after 1 and 4 years of the treatment and the repeat biopsy after 3 year

Key secondary outcomes

disease-specific survival rates

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

Maneuver

Interventions/Control_1

To perform the focal brachytherapy for the patients that were diagnosed with prostate cancers by using the MRI/US fusion guided targeted biopsies. The radiation area is between the half and one eighth of the prostate. The radiation area will be decided according to the location of the prostate cancer. All patients start or continue an intake of the alpha blockers after the focal brachytherapy. It is permitted to add an intake of drugs such as anticholinergic drugs and beta adrenergic agonists for the benign prostatic hyperplasia and the overactive bladder syndromes. Serum PSA will be checked every 3 months until 2 years after treatments and every 6 months afterwards. The emergence of the cancer suspected lesions will be examined by MRI. All patients receive repeat biopsies after 3 years of treatments and when the recurrence of prostate cancers were suspected by a PSA check or the MRI imaging.

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

Not applicable

Gender

Male

Key inclusion criteria

Patients must be under these conditions
1) Patients expect to live more than 10 years after the treatment
2) Prostate cancers are diagnosed by biopsies which they receive in our hospital
3) Patients can receive MRI imaging check and the clinical staging before biopsies is T2aN0.
4) PSA was 20.00 ng/ml or less.
5) The computed tomography (CT) of the chest/abdomen/pelvis and bone scintigraphy do not detect metastatic lesions
6) Functions of the main organs are maintained
6-1) Lliver function; AST and ALT is under 3 times the upper limit of the normal range.
6-2) Heart function;there is no severe abnormality in the electrocardiogram or normal it is confirmed that there is no severe abnormalities by the cardiac ultrasound.
6-3) Renal function; estimated GFR is 15 per minute or more.
7) There is no pubic arch interference in the prostate brachytherapy.
8) It is confirmed at least once that a residual volume is 200 ml or less by an ultrasound.
9) The prostate volume is 50 ml or less by the trans rectal ultrasound.
10) We obtain a written Informed consent of the participation of the study.
11) The result of the prostate biopsy was under these conditions
11-1) The biopsy was performed along the parasagittal, peripheral and base areas of the prostate with an interval of 5 mm. The core number of systematic biopsy is 16 or more and MRI/US fusion-guided biopsy was performed. If the volume of the prostate is small ,the base area of the biopsy can be abbreviated.
11-2) The lesions of the cancer detected core are limited in the targeted area by MRI/US fusion biopsy and the surrounding area.
11-3) The lesions of the cancer detected core was limited in the left or right lobe of the prostate.
12) The result of the biopsy meet any of these Gleason scores and the proportion of the cores.
12-1) Gleason score is 3+3
12-2) Gleason score is 3+4
12-3) Gleason score is 4+3 and the proportion of the core is 50 or less.

Key exclusion criteria

Patients must not be under these conditions
1) Patients who had past surgical histories of benign prostatic hyperplasia.
2) Patients who had severe mental disorders.
3) Patients who had other active cancers
4) Patients who doctors judge as unsuitable for this study

Target sample size

20

Name of lead principal investigator

1st name	Hisashi
Middle name
Last name	Matsushima

Organization

Tokyo Metropolitan Police Hospital

Division name

Department of Urology

Zip code

164-0001

Address

4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan

TEL

+81-03-5343-5611

Email

hmatsu53@me.com

Name of contact person

1st name	Yuji
Middle name
Last name	Hakozaki

Organization

Tokyo Metropolitan Police Hospital

Division name

Department of Urology

Zip code

164-0001

Address

4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan

TEL

+81-03-5343-5611

Homepage URL

Email

yhakozaki11012@gmail.com

Institute

Tokyo Metropolitan Police Hospital

Institute

Department

Personal name

Organization

Tokyo Metropolitan Police Hospital

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Metropolitan Police Hospital Clinical Review Comittee

Address

4-22-1 Nakano, Nakano-ku, Tokyo, Japan

Tel

+81-03-5343-5611

Email

yhakozaki11012@gmail.com

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

2017

Year

03

Month

08

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

Open public recruiting

Date of protocol fixation

2017

Year

03

Month

08

Day

Date of IRB

2017

Year

02

Month

28

Day

Anticipated trial start date

2017

Year

03

Month

09

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

07

Day

Last modified on

2020

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030340