UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049746 |
|---|---|
| Receipt number | R000056577 |
| Scientific Title | A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients |
| Date of disclosure of the study information | 2022/12/12 |
| Last modified on | 2024/03/18 17:54:39 |
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Basic information
Public title
A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients
Acronym
SMART PRO trial
Scientific Title
A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients
Scientific Title:Acronym
SMART PRO trial
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of stereotactic radiotherapy with MR linear accelerators with the dose of 26 Gy/2 fractions for very low/low/intermediate risk prostate cancer patients in NCCN risk classification
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Acute genitourinary adverse events of grade 2 or higher
Key secondary outcomes
Other acute adverse event rates, 5-year rate of radiotherapy-related late adverse events (91 days or later after radiotherapy initiation), PSA nadir after radiotherapy completion, 5-year PSA recurrence-free rate, 5-year clinical progression-free rate, 5-year disease-specific survival rate, 5-year distant metastasis-free survival rate, 5-year overall survival rate, PSA recurrence-free period, clinical progression-free period, disease-specific survival, overall survival, patient-reported outcomes, and health economic evaluation using the EQ-5D.
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
Ultrahypofractionated stereotactic radiotherapy of 26 Gy in 2 fractions in 1-2 weeks using MR linear accelerator
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) Histopatholologically confirmed prostate cancer.
2) Clinical stage of T1c-2cN0M0.
3) Any PSA level measured prior to enrollment is less than 20 ng/ml.
4) Gleason score of 6-7.
5) Very low/low risk or intermediate risk by NCCN guideline risk classification (2022 edition).
6) Patients with or without measurable disease.
7) Age of 18 years or older, and less than 80 years on the date of enrollment.
8) ECOG Performance status (PS) is 0 to 1.
9) No previous surgical treatment of the prostate (transurethral resection of the prostate, prostatic capsulotomy, orchiectomy, etc.), HIFU (high-intensity focused ultrasound), or chemotherapy other than hormone therapy.
10) International Prostate Symptom Score (IPSS) of 19 or less within 28 days prior to enrollment (same day of the week 4 weeks prior to enrollment is acceptable).
11) SpaceOAR is implanted in the rectal wall/prostate rather than in the Denovier space. SpaceOAR is implanted in the rectal wall/prostate, not in the Denovier space, and there is no significant worsening of urinary symptoms after implantation.
12) No prior radiation therapy within the presumable irradiation area in the present clinical trial, including treatment for other types of cancer.
13) No hormone-refractory tumors.
14) Written consent to participate in the study has been obtained from the patient.
15) The patient has been informed of other treatment options and is willing to undergo the study treatment.
Key exclusion criteria
1) Patients have an infectious disease requiring systemic treatment.
2) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
3) Patients with diabetes mellitus that is poorly controlled despite continuous use of insulin or oral hypoglycemic agents.
4) Patient has inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
5) Patient has undergone surgery in the abdominopelvic region, excluding appendicectomy and inguinal hernia.
6) Patient has active scleroderma or systemic lupus erythematosus.
7) Is considered by the investigator to be unsuitable for participation in this study.
8) Is taking anticoagulant or antiplatelet medication.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital
Division name
Depaertment of Radiation Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Tairo |
| Middle name | |
| Last name | Kashihara |
Organization
National Cancer Center Hospital
Division name
Depaertment of Radiation Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tkashiha@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.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
| 2022 | Year | 12 | Month | 12 | 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
There is no plans to share individual subject data at this time.
IPD sharing Plan description
There is no plans to share individual subject data at this time.
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056577
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