UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033344 |
|---|---|
| Receipt number | 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 | 2025/01/27 11:05:51 |
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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 | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
6608507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3762
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
6608507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3762
Homepage URL
mizo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Fakulty of Medicine
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
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
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
26
Results
Incidences of grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicities were 26.9% (N = 7) and 7.7% (N = 2), respectively.
Results date posted
| 2023 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median patient age was 73 years at the initiation of RT. According to the National Comprehensive Cancer Network (NCCN) risk classification, 1, 3, 10, and 12 patients had avorable intermediate-risk, unfavorable intermediate-risk, high-risk, and very high-risk disease, respectively.
Participant flow
Between August 9, 2018 and November 4, 2020, 26 patients were enrolled and gave signed consent. All proceeded to ratiation therapy (RT).
Adverse events
Incidences of grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicities were 26.9% (N = 7) and 7.7% (N = 2), respectively. Cumulative incidence rates of grade 2 or higher late GU and GI toxicities were 15.4% and 0.0% at 2 years, and 15.4% and 4.3% at 5 years, respectively.
Outcome measures
The 5-year biochemical failure-free survival and clinical failure-free survival rates were 75.2 and 80.5%, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036508
