UMIN-CTR Clinical Trial

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 (&ge; 2 hot spots) on bone scintigraphy prior to enrollment (3)Age &ge; 20 (4)Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2 (5)Life expectancy &ge; 6 months (6)Laboratory requirements: -Absolute neutrophil count (ANC) &ge; 1.5 x 109/L -Platelet count &ge; 100 x 109/L -Hemoglobin &ge; 10.0 g/dL -Total bilirubin level &le; 1.5 institutional upper limit of normal (ULN) -Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) &le; 2.5 ULN -Creatinine &le; 1.5 ULN, and estimated glomerular filtration rate (GFR) &ge; 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
Email	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
Email	t-tsukagoshi@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044531