UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057234 |
|---|---|
| Receipt number | R000065419 |
| Scientific Title | A registry study of CHemotherApy-ineligible Metastatic hormone-sensitive Prostate cancer |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/03/07 09:59:29 |
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Basic information
Public title
A registry study of CHemotherApy-ineligible Metastatic hormone-sensitive Prostate cancer
Acronym
CHAMP study
Scientific Title
A registry study of CHemotherApy-ineligible Metastatic hormone-sensitive Prostate cancer
Scientific Title:Acronym
CHAMP study
Region
| Japan |
Condition
Condition
metastatic hormone-sensitive prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current state of treatment and prognosis for metastatic hormone-sensitive prostate cancer (mHSPC) that does not receive chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to CRPC-progression
Key secondary outcomes
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
1) Those diagnosed with mHSPC
2) Those aged 20 years or older at the time of consent
3) Those who are able to take medication orally
4) Those receiving drug therapy for mHSPC that does not include chemotherapy
5) Those who have given written consent to participate in this study
Key exclusion criteria
1) Those who have not had a histological diagnosis of prostate cancer
2) Those who have had a malignant tumour other than prostate cancer within the last 3 years
3) Those who have serious (requiring hospitalisation) and uncontrollable complications other than malignant tumours
4) Those who have a seizure disorder requiring anticonvulsant treatment (except those in a clinically stable period or those without seizures)
5) Those with severe liver dysfunction
6) Those with a history of hypersensitivity to the components of the mHSPC treatment drug
7) Those who are unable or unwilling to cooperate with the procedures of this study
8) Those who are deemed by the treating physician to be unsuitable subjects for this study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Hashimoto |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
0608543
Address
Minami 1-Jo, Nishi 16 Cho-me, Chuo-ku, Saspporo
TEL
011612111
kohei@cj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Hashimoto |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
0608543
Address
Minami 1-Jo, Nishi 16 Cho-me, Chuo-ku, Saspporo
TEL
011612111
Homepage URL
kohei@cj9.so-net.ne.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
not available
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
Sapporo Medical University
Address
Minami 1-Jo, Nishi 16 Cho-me, Chuo-ku, Saspporo
Tel
011-611-2111
to-rskk@sapmed.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
| 2026 | Year | 01 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not available
Management information
Registered date
| 2025 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065419
