UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057157 |
|---|---|
| Receipt number | R000065338 |
| Scientific Title | Multicenter randomized controlled trial to evaluate the superiority of peripheral dose escalation in stereotactic radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/02/27 18:46:34 |
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Basic information
Public title
Multicenter randomized controlled trial to evaluate the superiority of peripheral dose escalation in stereotactic radiotherapy for prostate cancer
Acronym
SPIDER III
Scientific Title
Multicenter randomized controlled trial to evaluate the superiority of peripheral dose escalation in stereotactic radiotherapy for prostate cancer
Scientific Title:Acronym
Multicenter randomized controlled trial to evaluate the superiority of peripheral dose escalation in stereotactic radiotherapy for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compare the efficacy and safety between two methods of stereotactic radiation therapy for prostate cancer:1) a method that does not set a dose escalation area (Group A), and 2) a method that increases the dose across the entire peripheral zone of the prostate while maintaining a safety margin from the bladder, urethra, and rectum (Group B).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 8-year PSA recurrence-free survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Standard Radiotherapy
Interventions/Control_2
Dose escalated Radiotherapy
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Pathologically diagnosed as prostate cancer (adenocarcinoma)
2) Unfavorable intermediate risk, high risk, and very high risk according to NCCN classification
3) PSA value is less than 100 ng/ml
4) The age on the registration date is between 20 years old and 90 years old
5) ECOG Performance status (PS) 0 to 1
6) People who can take MRI
7) Written consent has been obtained
Key exclusion criteria
(1) Patients with active overlapping cancers (excluding those with synchronous overlapping cancers expected to have a prognosis of over 5 years due to treatment or those with asynchronous overlapping cancers expected to have a prognosis of over 5 years).
(2) Patients with uncontrolled diabetes (with HbA1c of 8.0% or higher as a guideline).
(3) Patients deemed by their primary physician to have severe complications such as collagen diseases, heart diseases, respiratory diseases, or liver diseases.
(4) Patients who have mental illness or psychiatric symptoms that make participation in the trial difficult.
(5) Patients who have previously received radiation therapy to the pelvic area.
(6) Patients who have undergone surgical treatment for the prostate (such as transurethral resection of the prostate, subcapsular prostatectomy, orchiectomy, etc.) or HIFU (high-intensity focused ultrasound therapy).
(7) Patients who have received chemotherapy for prostate cancer other than androgen deprivation therapy.
(8) Patients with inflammatory bowel diseases such as Crohn's disease and ulcerative colitis.
(9) Patients for whom risk organs such as the small intestine and colon are in close proximity to the PTV estimated by imaging diagnosis, making it impossible to adhere to dose constraints.
(10) Patients for whom the attending physician deems participation in clinical trials inappropriate.
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishiyama |
Organization
Kitasato University school of medicine
Division name
Radiation Oncology
Zip code
252-0329
Address
1-15-1 Sagamiharashi-minamiku, Kanagawa, Japan
TEL
042-778-8453
hishiyam@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishiyama |
Organization
Kitasato University school of medicine
Division name
Radiation Oncology
Zip code
252-0329
Address
1-15-1 Sagamiharashi-minamiku, Kanagawa, Japan
TEL
042-778-8453
Homepage URL
hishiyam@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Institutional Review Board of Kitasato University School of Medicine and Hospital
Address
1-15-1 Sagamiharashi-minamiku, Kanagawa, Japan
Tel
042-778-8273
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2035 | 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
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065338
