UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046163 |
|---|---|
| Receipt number | R000052662 |
| Scientific Title | Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0) |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/10/02 14:48:15 |
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Basic information
Public title
Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0)
Acronym
Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) for non-metastatic prostate cancer (T1c-T4N0M0)
Scientific Title
Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0)
Scientific Title:Acronym
Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) for non-metastatic prostate cancer (T1c-T4N0M0)
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of a hypofractionated proton beam therapy of 51.6Gy(RBE) in 12 fractions (3 weeks), using real-time-image gated spot-scanning system, for non-metastatic prostate cancer (T1c-T4N0M0)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Genitourinary early adverse effects (at and up to 13 weeks: from the start of treatment)
Genitourinary late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment)
Key secondary outcomes
Genitourinary late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment)
Gastrointestinal early adverse effects (at and up to 13 weeks: from the start of treatment)
Gastrointestinal late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment)
Gastrointestinal late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment)
Freedom from biochemical failure
Freedom from biochemical or clinical failure
Disease specific survival
Overall survival
Assessment of the quality of life and sexual function following proton therapy. [ Time Frame: Baseline, Months 3(+/- 0.5), 6(+/- 1.5), 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ]
EPIC (Expanded Prostate Cancer Index Composite)
SF (Short Form Health Survey) -12
Assessment of IPSS (International Prostate Symptom Score) [ Time Frame: Baseline, Weeks 4(+/- 1), 8(+/- 1), Months 3(+/- 0.5), 6(+/- 1.5), 9(+/- 1.5), 12(+/- 1.5), 18(+/- 2.5), 24(+/- 2.5), 30(+/- 2.5), 36(+/- 2.5), 42(+/- 2.5), 48(+/- 2.5), 54(+/- 2.5), 60(+/- 2.5)]
Assessment of SHIM (Sexual Health Inventory for Men) [ Time Frame: Baseline, Months 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ]
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks)
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
Pathological (histologically) proven diagnosis of prostatic adenocarcinoma.
Patients must be between 20 years old and 84 years old.
Eastern Cooperative Oncology Group(ECOG) Performance status 0-2.
Clinical stage T1c-T4N0M0 (UICC 8th edition) ; absence of metastasis by CT, MRI, bone scan or metabolic images.
Other radiation therapy (except for proton beam therapy), surgery or chemotherapy will not be used.
Patient must be able to provide study specific informed consent.
Key exclusion criteria
Prior radiotherapy to the pelvic area
Prior prostate cancer therapy such as: prostatectomy, radiation therapy, chemotherapy or high intensity focused ultrasound (HIFU) . Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included.
Second invasive malignancy (except of carcinoma in situ, treated by optimal therapy) if not controlled within last 5 years.
It is clinically difficult to place fiducial markers into prostate.
There is uncontrollable inflammation in pelvic lesion or inflammatory systemic disease.
It is difficult to provide study-specific informed consent prior to study entry.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Aibe |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5620
a-ib-n24@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Aibe |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5620
Homepage URL
a-ib-n24@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Department of Radiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Ethical Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052662
