UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057476 |
|---|---|
| Receipt number | R000065666 |
| Scientific Title | Prospective observational study on the high-precision proton radiation therapy with 12 fractions for localized and locally advanced prostate cancer |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/01 12:12:31 |
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Basic information
Public title
Prospective observational study on the high-precision proton radiation therapy with 12 fractions for localized and locally advanced prostate cancer
Acronym
HFPRT-PC01
Scientific Title
Prospective observational study on the high-precision proton radiation therapy with 12 fractions for localized and locally advanced prostate cancer
Scientific Title:Acronym
HFPRT-PC01
Region
| Japan |
Condition
Condition
localized and locally advanced prostate cancer (T1c-T4N0M0)
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the safety and efficacy of the moderately hypofractionated high-precision proton radiation therapy (51.6GyE in 12 fractions over 3 weeks)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grade 2 or more genitourinary adverse effects evaluated based on RTOG-EORTC toxicity criteria
Key secondary outcomes
acute genitourinary adverse event, 3-year cumulative late genitourinary adverse event, 5-year cumulative late genitourinary adverse event, acute gastrointestinal adverse event, 3-year cumulative late gastrointestinal adverse event, 5-year cumulative late gastrointestinal adverse event, biochemical recurrence-free interval, biochemical recurrence-free survival, recurrence-free survival, pattern of recurrence, disease-specific survival, overall survival, and transition of PRO (Patient-Reported Outcomes) based on HRQOL (Health-Related Quality of Life) assessment (EPIC, SF-12, IPSS, OABSS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 86 | years-old | > |
Gender
Male
Key inclusion criteria
The patient is scheduled to receive the proton radiation therapy of 51.6 GyE in 12 fractions over 3 weeks and meets the following criteria.
1. The ECOG performance status is 0-2.
2. Prostate cancer (adenocarcinoma) has been pathologically diagnosed through prostate biopsy.
3. Within 130 days of initiating treatment for prostate cancer, including hormone therapy, various examinations (physical examination, PSA measurement, pelvic MRI, chest and abdominal CT, and bone scintigraphy) have confirmed a clinical stage of T1c-4N0M0 based on the 8th edition of the TNM classification by the Union for International Cancer Control (UICC), and the risk classification according to the 2025 edition (Version 1) of the NCCN risk classification has been determined.
4. Until registration in this study, the patient has not received any treatment other than hormone therapy for prostate cancer, including surgery, radiation therapy, or chemotherapy.
5. After registration in this study, the patient is not scheduled to receive any treatment other than hormone therapy and proton radiation therapy at 51.6 GyE in 12 fractions over 3 weeks (4 sessions per week).
6. The patient has received a sufficient explanation regarding participation in this study, fully understands the details, and has provided written informed consent voluntarily.
Key exclusion criteria
1. Those who have active synchronous or metachronous double cancers at the time of study registration. However, carcinoma in situ, mucosal carcinoma-equivalent lesions, and skin cancer (excluding malignant melanoma) that are considered cured by appropriate treatment are not included.
2. Those with a history of surgical treatment, high-intensity focused ultrasound, or cryotherapy for the target lesion before study registration.
3. Those with a history of pelvic radiation therapy before study registration.
4. Those with a history of transurethral resection of the prostate (TUR-P) before study registration.
5. Those with a history of severe urinary dysfunction requiring catheter insertion, cystostomy, or nephrostomy within six months before study registration.
6. Those with a history of anticancer drug therapy (including chemotherapy, molecular-targeted therapy, immunotherapy, and hormone therapy) for diseases other than the target lesion within two years before study registration. This includes anticancer drug treatment for rheumatoid arthritis.
7. Those with a history of treatment with 5alpha-reductase inhibitors such as dutasteride or finasteride within two years before study registration.
8. Those who have refractory infections or inflammatory diseases in the pelvis at the time of study registration or have chronic inflammatory diseases requiring systemic treatment.
9. Those with metallic implants in the pelvic region who, according to the principal investigator or sub-investigators, are deemed unable to undergo proton beam therapy safely.
10. Those who, according to the principal investigator or sub-investigators, are deemed unsuitable for fiducial marker placement in the prostate.
11. Those who, according to the principal investigator or sub-investigators, are deemed unsuitable for participation in this study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Suzuki |
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
gensuzu@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
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Kyoto Prefectural University of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the following genitourinary and lower gastrointestinal adverse events will be evaluated using CTCAE v5.0 and RTOG-EORTC toxicity criteria, along with disease status, at the following time points: before proton radiation therapy (PRT), during PRT, 7 weeks after the start, 16 weeks after the start, 6 months after the start, and every 6 months thereafter up to the fifth year after the start of PRT.
Genitourinary Adverse Events: frequent urination, urgency, urinary incontinence, urinary retention (including weak stream and residual urine), dysuria, hematuria, urinary tract infection, and other genitourinary adverse events
Lower Gastrointestinal Adverse Events: diarrhea, fecal incontinence, proctitis, rectal bleeding (hematochezia), anal pain/rectal pain, and other lower gastrointestinal adverse events
Additionally, PRO (Patient-Reported Outcome) assessments will be conducted using EPIC, SF-12, IPSS, and OABSS at the following time points: before PRT, 7 weeks after the start, 16 weeks after the start, 6 months after the start, 1 year after the start, and every 1 year thereafter up to the fifth year after the start of PRT.
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065666
