UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026213
Receipt number R000029385
Scientific Title Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer
Date of disclosure of the study information 2017/02/20
Last modified on 2021/08/23 10:26:38

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Basic information

Public title

Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer

Acronym

Prostate stereotactic body radiotherapy with a hydrogel spacer

Scientific Title

Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer

Scientific Title:Acronym

Prostate stereotactic body radiotherapy with a hydrogel spacer

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) with the use of hydrogel spacer for prostate cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

All acute gastrointestinal toxicity

Key secondary outcomes

Dose Volume Histogram
Adverse events related to spacer insertion
Success rate of spacer insertion
Position of the spacer at the last day of radiotherapy
Acute genitourinary toxicity
Late gastrointestinal and genitourinary toxicity
Other toxicities related to radiotherapy
QOL:Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy Prostate (FACT P)
The International Prostate Symptom Score (IPSS)
Biochemical failure free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Insertion of the hydrogel spacer

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

80 years-old >=

Gender

Male

Key inclusion criteria

Prostate cancer patients
Pathologically diagnosed adenocarcinoma
Age >= 20 years, <= 80 years
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade 0-2
Number of prostate core needle biopsies >= 8
Patients must provide written, informed consent before any study procedures occur

Key exclusion criteria

Patients with lymph node metastasis and or distant metastasis
History of prostate cancer treatment (surgery, high intensity focused ultrasound, chemotherapy)
Hormone therapy >= 12 months before radiotherapy
History of pelvic radiotherapy
History of any other malignancy within 2 years (except carcinoma in situ)
Severe cardiovascular disease
Severe respiratory disease
Liver disease (AST, ALT >20 x ULN)
Severe kidney disease requiring hemodialysis
Unable to provide written informed consent
Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
History of lowerpelvic surgery
Metal in pelvic or near pelvic area (e.g. total hip replacement) affecting pelvic CT scan
Bleeding tendency that may disrupt hydrogel spacer insertion (Plt <= 100000, PT INR > 1.5 ULN (with anticoagulant, PT INR > 2.5 ULN), APTT >= 2 x ULN)
Unable to insert ultrasound probe (e.g. anal stenosis)
Allergic to local anesthetics
Considered not appropriate for the study by investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Mami
Middle name
Last name Ogita

Organization

The University of Tokyo Hospital

Division name

Radiology

Zip code

Mami

Address

7-3-1 Hongo Bunkyo-ku Tokyo Japan

TEL

08031373772

Email

ogitam-rad@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Mami
Middle name
Last name Ogita

Organization

The University of Tokyo Hospital

Division name

Radiology

Zip code

1138655

Address

7-3-1 Hongo Bunkyo-ku Tokyo Japan

TEL

03-3815-5411

Homepage URL


Email

ogitam-rad@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo Bunkyo-ku Tokyo Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

東京大学医学部附属病院/The University of Tokyo Hospital


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 Day


Related information

URL releasing protocol

http://www.u-tokyo-rad.jp/index.html

Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

42

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

Main results already published

Date of protocol fixation

2017 Year 02 Month 08 Day

Date of IRB

2017 Year 02 Month 08 Day

Anticipated trial start date

2017 Year 02 Month 20 Day

Last follow-up date

2021 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 19 Day

Last modified on

2021 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name