UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044790
Receipt number R000050022
Scientific Title Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy
Date of disclosure of the study information 2021/07/09
Last modified on 2021/07/08 11:56:48

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Basic information

Public title

Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy

Acronym

Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy

Scientific Title

Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy

Scientific Title:Acronym

FBTPOC study

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety and efficacy of focal brachytherapy for localized prostate cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the change at 3 months after focal brachytherapy (FBT) from baseline in the mean 24 h urinary frequency

Key secondary outcomes

1, PSA value before FBT, and at 1,3,6,12,18,24,30,and 36 months after FBT.
2, biochemical failure free survival by Stuttgart definition (PSA nadir + 1.2ng/ml)
3, biochemical failure free survival by Phenix definition (PSA nadir + 2.0ng/ml)
4,pathological findings by saturation biopsy 36 months after FBT
5,findings on MRI 36months after FBT
6,radical treatment free suvival
7,the change at 1,3,6,12,18,24,30,and 36 months after FBT from baseline in IPSS, OABSS, QOL, SHIM, SF-8, and EPIC
8, the change at 1,3,6,and 12 months after FBT from baseline in mean volume voided per micturition, the change at 1,6,and 12 months after FBT from baseline in the mean 24 h urinary frequency
9, the change at 1,3,6,12,18,24,30, and 36months after FBT from baseline in post-voiding residual volume
10, Genitourinary and gastrointestional toxicity (CTCAE version 5.0)
11, comparison of chronological change of PSA between patients with positive findings on saturation biopsy at 36 months after FBT and those with negative findings
12,comparison with historical data (patients who underwent low-dose-rate brachytherapy between May 2010 and April 2020) in the change of IPSS, OABSS, QOL, SHIM, SF-8, EPIC, the mean 24h urinary frequency, mean volume voided per micturition, and toxicity.


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

Maneuver

Interventions/Control_1

focal brachytherapy

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

85 years-old >=

Gender

Male

Key inclusion criteria

1, patients with prostate cancer who undergo low-dose-brachytherapy
2, Gleason score 3+3 or 3+4, the number of positive core on hemi lobe by prostate biopsy (8-12 cores)
3, PSA < 10ng/mL
4, cT1 or cT2a on MRI
5, no metastatic findings on bone scintigraphy, MRI, and CT
6, >20, <85 years old

Key exclusion criteria

1, Patients who underwent TUR-P
2, Patients with pubic arch interference
3, history of androgen deprivation therapy
4, severe mental disorders
5, systemic and continuous use of steroidal drugs
6, history of radiation therapy on pelvis
7, inflammatory bowel disease
8, severe diabetes
9,patients who have difficulty to hold operative position
10, abnormal findings on blood examination

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Nakai
Middle name
Last name Yasushi

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8521

Address

840 Shijyocho, Kashihara, Nara, Japan

TEL

0744223051

Email

nakaiyasusiuro@live.jp


Public contact

Name of contact person

1st name Nakai
Middle name
Last name Yasushi

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8521

Address

840 Shijyocho, Kashihara, Nara, Japan

TEL

0744223051

Homepage URL


Email

nakaiyasusiuro@live.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nihon Medi-Physics Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nara

Address

840 Shijyocho, Kashihara, Nara, Japan

Tel

0744223051

Email

ino_rinri@naramed-u.ac.jp


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

2021 Year 07 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 01 Day

Date of IRB

2021 Year 03 Month 24 Day

Anticipated trial start date

2021 Year 07 Month 09 Day

Last follow-up date

2026 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 08 Day

Last modified on

2021 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050022


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name