UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049304 |
|---|---|
| Receipt number | R000056158 |
| Scientific Title | Randomized Phase II selection trial of Stereotactic Prostate Irradiation with Dose Escalated Region |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2026/04/28 09:50:40 |
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Basic information
Public title
Randomized Phase II selection trial of Stereotactic Prostate Irradiation with Dose Escalated Region
Acronym
SPIDER II trial
Scientific Title
Randomized Phase II selection trial of Stereotactic Prostate Irradiation with Dose Escalated Region
Scientific Title:Acronym
SPIDER II trial
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare a local dose escalation technique for the tumor visualized by MRI (group A) with a peripheral dose escalation technique for all prostate parenchyma excluding bladder, urethra, and rectum (group B), and to select the group to be compared with the standard treatment in the future phase III trial.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
>=Grade 2 toxicity rates at 1 year after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
focal dose escalation
Interventions/Control_2
peripheral dose escalation
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) Patients pathologically diagnosed with prostate cancer (adenocarcinoma)
(2) Un-favorite intermediate-, high-, or very-high-risk patients according to the NCCN classification
(3) Patients with PSA level (ng/ml) less than 100
(4) Patients aged between 20 and 90 on the date of informed consent
(5) Performance status (PS) is an ECOG criterion for patients with a score of 0 to 1.
(6) Patients who can detect lesions on T2-weighted or diffusion-weighted MRI
(7) Written consent has been obtained
Key exclusion criteria
(1) Patients with active multiple cancers (excluding metachronous multiple cancers with an expected prognosis of 5 years or longer and synchronous multiple cancers with an expected prognosis of 5 years or longer with treatment)
(2) Patients with uncontrolled diabetes (HbAlc 8.0% or more as a guideline)
(3) Patients judged by the attending physician to have serious complications such as connective tissue disease, heart disease, respiratory disease, liver disease, etc.
(4) Patients who are complicated by psychosis or psychiatric symptoms and are judged to be difficult to participate in the study
(5) Patients who have previously received radiotherapy to the pelvis
(6) Patients who have undergone surgical therapy for the prostate (transurethral prostatectomy, subcapsular prostatectomy, orchiectomy, etc.) or HIFU (high-intensity focused ultrasound)
(7) Patients who received chemotherapy other than androgen deprivation therapy for prostate cancer
(8) Patients with inflammatory bowel disease such as Crohn's disease or ulcerative colitis
(9) Patients who are judged to be unable to comply with dose restrictions due to the proximity of risk organs such as the urethra and large intestine to the PTV estimated by diagnostic imaging.
(10) Patients who are judged inappropriate for clinical trial participation by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishiyama |
Organization
Kitasato university school of medicine
Division name
Department of radiation oncology
Zip code
252-0329
Address
1-15-1 Kitasato, Sagamiharashi-minamiku, Kanagawa, JAPAN
TEL
042-778-8111
hishiyam@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Inaba |
Organization
National cancer center hospital
Division name
Department of radiation oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3545-2511
Homepage URL
koinaba@ncc.go.jp
Sponsor or person
Institute
Kitasato univeristy
Institute
Department
Personal name
Funding Source
Organization
Kitasato univeristy
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
Kitasato University School of Medicine, Hospital Ethics Committee
Address
1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa, JAPAN
Tel
042-778-8111
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
| 2022 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0167814025003949?via%3Dihub
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0167814025003949?via%3Dihub
Number of participants that the trial has enrolled
66
Results
At a median follow-up of 12 months, the incidence of Grade 2 or higher gastrointestinal or genitourinary AEs related to radiotherapy was 7.4% in Group A and 13.5% in Group B (p=0.68) (Acute Grade 2 AEs: 3.7% in Group A and 13.5% in Group B, Late Grade 2 AEs: 3.7% in Group A and 0% in Group B).
Results date posted
| 2026 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who have been pathologically diagnosed with prostate cancer (adenocarcinoma).
Patients classified as unfavorable intermediate risk, high risk, or very high risk according to the NCCN risk classification.
Patients with a PSA level of less than 100 ng/mL
Patients aged 20 years or older and 90 years or younger at the time of informed consent.
Patients with a Performance Status (PS) of 0 to 1 according to the ECOG criteria.
Patients with a detectable lesion on MRI, identified on T2weighted imaging and/or diffusion weighted imaging.
Patients who have provided written informed consent.
Participant flow
After confirming that the eligible patient meets all inclusion criteria and none of the exclusion criteria, the patient will be registered through the UMIN Medical Research Support (Case Registration and Allocation) System Cloud Version (INDICE Cloud).
At the time of registration, patients will be randomly assigned within INDICE Cloud in a 1 to 1 ratio to either the tumor local dose escalation group (Group A) or the marginal parenchymal dose escalation group (Group B).
In this study, no allocation adjustment factors will be used, and assignment will be performed using a completely random allocation method.
The detailed procedures of the randomization will not be disclosed to the investigators at the participating institutions.
Adverse events
At a median follow-up of 12 months, the incidence of Grade 2 or higher gastrointestinal or genitourinary AEs related to radiotherapy was 7.4% in Group A and 13.5% in Group B (p=0.68) (Acute Grade 2 AEs: 3.7% in Group A and 13.5% in Group B, Late Grade 2 AEs: 3.7% in Group A and 0% in Group B).
Outcome measures
A total of 28 patients in Group A and 37 in Group B were enrolled, with 27 in Group A and 37 in Group B receiving the protocol treatment. The median age was 75 years in Group A and 76 years in Group B. The median PSA was 9.7 ng/mL (range: 6.1-41.3) in Group A, 10.9 ng/mL (range: 5.6-45.2) in Group B. Group A had 9 patients and Group B had 15 with unfavorable intermediate risk; 14 and 15 patients, respectively, were classified as high risk, and 4 and 7 patients as very high risk. Hormone therapy was administered to 26 patients in Group A and 35 in Group B. At a median follow-up of 12 months, the incidence of Grade 2 or higher gastrointestinal or genitourinary AEs related to radiotherapy was 7.4% in Group A and 13.5% in Group B (p=0.68) (Acute Grade 2 AEs: 3.7% in Group A and 13.5% in Group B, Late Grade 2 AEs: 3.7% in Group A and 0% in Group B).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056158
