UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039051 |
|---|---|
| Receipt number | R000044531 |
| Scientific Title | Preliminarily comparison of multiple radiographic modalities in evaluation of response to treatment of bone metastasis with Ra-223 |
| Date of disclosure of the study information | 2020/01/04 |
| Last modified on | 2020/01/04 16:20:29 |
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Basic information
Public title
Preliminarily comparison of multiple radiographic modalities in evaluation of response to treatment of bone metastasis with Ra-223
Acronym
Comparison of radiographic modalities for Ra-223
Scientific Title
Preliminarily comparison of multiple radiographic modalities in evaluation of response to treatment of bone metastasis with Ra-223
Scientific Title:Acronym
Comparison of radiographic modalities for Ra-223
Region
| Japan |
Condition
Condition
CRPC patients with bone metastasis
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily compare multiple modalities (SPECT-CT, FDG-PET, and MRI) in terms of predicting overall survival after Ra-223 treatment in CRPC patients with bone metastasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To preliminarily compare multiple modalities (SPECT-CT, FDG-PET and MRI) in terms of predicting overall survival after Ra-223 treatment in CRPC patients with bone metastasis
Key secondary outcomes
To preliminarily compare multiple modalities in terms of predictability of SSE-FS
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
| Not applicable |
Gender
Male
Key inclusion criteria
Symptomatic metastatic castration resistant prostate cancer with bone metastasis with no known visceral metastasis
(1)Histologically or cytologically confirmed prostate cancer with medical or surgical castration, and who to be treated with Ra-223
(2)With bone metastases (≥ 2 hot spots) on bone scintigraphy prior to enrollment
(3)Age ≥ 20
(4)Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2
(5)Life expectancy ≥ 6 months
(6)Laboratory requirements:
-Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
-Platelet count ≥ 100 x 109/L
-Hemoglobin ≥ 10.0 g/dL
-Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
-Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN
-Creatinine ≤ 1.5 ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
Key exclusion criteria
(1)Prior treatment within 1 week before enrollment or any combination use during the study with abiraterone and prednisone/prednisolone, enzalutamide, or chemotherapies
(2)Prior hemibody external radiation
(3)Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks
(4)Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry
(5)Other malignancy treated prior to enrollment (except non-melanoma skin cancer or low-grade superficial bladder cancer)
(6)History of visceral metastasis, or visceral metastases as assessed by screening imaging examination
(7)Known brain metastasis
(8)Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
(9)Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging)
(10)Any other serious illness or medical condition
(11)Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study
(12)Those who have any contraindication to MRI or other Magnetic Imaging
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | Fukushima |
Organization
Nippon Medical School Hospital
Division name
Department of Radiology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3822-2131
fuku@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Tsukagoshi |
Organization
Nippon Medical School Hospital
Division name
Department of Radiology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3822-2131
Homepage URL
t-tsukagoshi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
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
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
Tel
+81-3-3822-2131
app-ccr@nms.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
日本医科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Imaging modalities for determining the therapeutic effect of Ra-223 for CRPC induced bone metastasis has not been established.
Management information
Registered date
| 2020 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044531
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