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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033344
Receipt No. R000036508
Scientific Title A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer
Date of disclosure of the study information 2018/07/15
Last modified on 2019/01/09

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Basic information
Public title A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer
Acronym highly-hypofractionated DWA radiation therapy for high-risk prostate cancer
Scientific Title A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer
Scientific Title:Acronym highly-hypofractionated DWA radiation therapy for high-risk prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of highly-hypofractionated Dynamic WaveArc radiation therapy (57 Gy/54 Gy/15 fractions/3 weeks) with simultaneous integrated boost for patients with high-risk prostate cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incidences of acute adverse events
Key secondary outcomes Incidences of late adverse events at 2 years
PSA recurrence-free suravival rate at 2 years

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
Maneuver
Interventions/Control_1 Highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost (57 Gy/54 Gy/15 fractions/3 weeks) is applied after 6 to 12 months neoadjuvant hormonal therapy.
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male
Key inclusion criteria 1) Histologically confirmed as adenocarcinoma of the prostate.
2) Prostate cancer cases and diagnosed as cT2a-T3a and classified to high-risk based on MRI, CT and bone scintigraphy before the initiation of neoadjuvant hormonal therapy.
3) Neoadjuvant hormonal therapy is performed.
4) Age at the registration is >=50 and <80 years old.
5) Performance status is 0 or 1 with Eastern Cooperative Oncology Group definition.
6) Cases submitted a written informed consent.
7) The basic blood examinations, including serum prostate-specific antigen (PSA) level was performed before the initiation of neoadjuvant hormonal therapy.
Key exclusion criteria 1) cT3a, iPSA >=30 ng/ml, and GS >= 4+4
2) active double cancer (i.e., overlapping cancer or asynchronous cancer within 5 years, except carcinoma in situ, intramucosal cancer, and other equivalent lesions)
3) Uncontrolled diabetes mellitus (HbA1c>+8.4%)
4) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease.
5) Psychotic disease
6) History of pelvic irradiation
7) History of pelvic surgery except for appendectomy and femoral herniation.
8) Surgical managements to the prostate
9) Chemotherapy to the prostate cancer
10) Inflammatory bowel diseases
11) Cases who are difficult to discontinue the administration of anticoagulant drugs.
12) Cases who are considered difficult to achieve dose constrain because of risk organs.
13) Cases with diffuse or large prostatic lesions.
14) Cases with significant metal artifact on pelvic CT images.
15) Cases who are difficult to achieve dose constrain at treatment planning.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 15 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
2018 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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