UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061315 |
|---|---|
| Receipt number | R000069765 |
| Scientific Title | A single-arm clinical trial on ultra-hypofractionated radiotherapy using an MR linear accelerator for prostate cancer with preserved sexual function |
| Date of disclosure of the study information | 2026/04/23 |
| Last modified on | 2026/04/20 19:16:39 |
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Basic information
Public title
A single-arm clinical trial on ultra-hypofractionated radiotherapy using an MR linear accelerator for prostate cancer with preserved sexual function (SMART pro II study)
Acronym
Clinical trial on ultra-hypofractionated radiotherapy with sexual function preservation for prostate cancer
Scientific Title
A single-arm clinical trial on ultra-hypofractionated radiotherapy using an MR linear accelerator for prostate cancer with preserved sexual function
Scientific Title:Acronym
SMART pro II study
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate the effectiveness of radiotherapy using an MR linear accelerator to reduce the neurovascular bundle (NVB) dose in prostate cancer patients classified as very low to favorable intermediate risk according to the NCCN risk classification, who wish to preserve sexual function. The primary endpoint will be sexual function at 24 months after the start of treatment, measured by the EPIC (9-item sexual function score).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 24 months post-treatment, is the average total score of the 13 items (out of 44 points) in questions 17-23 regarding sexual function within the EPIC score maintained at 80% of the average score before treatment?
Key secondary outcomes
Sexual function at 60 months (compared to pre-treatment)
Biochemical recurrence-free rate (defined as an increase of Nadir +2 ng/ml or higher, according to the Phoenix definition of RTOG-ASTRO).
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
The dose will be 13 Gy per session, for a total of two sessions, resulting in a total dose of 26 Gy. The dose prescription will be set so that 95% of the CTV (urethra + 1 mm) is irradiated at a dose of 26 Gy/2 Fr (D95 prescription). However, the following dose constraints must be observed.
NVB (side that can be preserved): D0.1 cc < 26.0 Gy, V24.7 Gy < 60%, V23.4 Gy < 70%, V19.5 Gy < 90%
Penile bulb: D50 < 15 Gy
Cavernosus: D0.1 cc < 12 Gy
Internal pudendal artery: D0.1 cc < 14 Gy
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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Risk classification according to NCCN guidelines: very low to favorable intermediate
(2) Strong desire for preservation of sexual function and ECOG PS: 0-1
(3) Eligible for treatment with MR linear accelerator
(4) No lymph node or distant metastasis on imaging
(5) No history of smoking, or has quit smoking
(6) Well-controlled diabetes (HbA1c < 7.0%)
Key exclusion criteria
1) Patients already receiving hormone therapy
2) Patients with a history of pelvic radiation therapy
3) Patients with a biopsy positivity rate of 33.3% or higher in both lobes
4) Patients with PI-RADS >=4 lesions within 5 mm of the NVB on both sides of the bilateral MRI before treatment
5) Patients with an EPIC combined sex score of 30 or less
6) Patients taking anticoagulants or antiplatelet drugs
7) Patients with psychosis or psychiatric symptoms who are deemed unable to participate in the study
8) Patients whom the principal investigator deems unsuitable for inclusion in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku, Sendai, Japan
TEL
022-717-7312
keiichi.jingu.e8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku, Sendai, Japan
TEL
022-717-7312
Homepage URL
noriyoshi.takahashi.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Elekta, K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Clinical Research Ethics Committee
Address
1-1 Seiryou-Chou, Aobaku, Sendai, Japan
Tel
022-717-7000
ec-hosp@grp.tohoku.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
東北大学病院（宮城県）、大阪公立大学病院（大阪府）、千葉大学付属病院（千葉県）、埼玉医科大学国際医療センター（埼玉県）、国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 23 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069765
