UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037127 |
|---|---|
| Receipt number | R000042307 |
| Scientific Title | The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in Japan |
| Date of disclosure of the study information | 2019/06/21 |
| Last modified on | 2024/11/20 12:48:40 |
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Basic information
Public title
The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in Japan
Acronym
J-ROCK
Scientific Title
The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in Japan
Scientific Title:Acronym
Japan mHNPC Registry
Region
| Japan |
Condition
Condition
High-risk metastatic hormone-naive prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for patients with high-risk mHNPC in the real-world setting in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for patients with high-risk mHNPC in the real-world setting in Japan
Key secondary outcomes
1) Proportion of patients who achieve prostate-specific antigen (PSA) less than 0.2 ng/mL within a year from registration
2) PSA progression-free survival (PSA-PFS) and 2-year PSA-PFS rate
3) PFS and 3-year PFS rate
4) OS and 3-year OS rate
5) Cancer specific survival (CSS) and 3-year CSS rate
6) Serum testosterone kinetics (if appropriate)
7) Subsequent treatment
8) Time to subsequent treatment (TTST) for prostate cancer
9) Time to symptomatic skeletal event (TTSSE)
10) Bone mineral density (BMD) kinetics (if appropriate)
11) Safety in the usual clinical practice
12) PRO by FACT-P, PHQ-9, and MoCA (if appropriate)
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. Male aged more than 20 years.
2. Documented diagnosis of mHNPC after 1 May 2019.
3. Should have at least 2 of the 3 following high-risk factors: a Gleason score of more than 8, at least 3-bone lesions, or the presence of visceral metastasis when diagnosed with mHN PC.
4. Willing to receive ADT containing regimens for high-risk mHNPC in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC.
5. Possess Japanese nationality.
6. Each patient (or their legally acceptable representative) must sign an ICF indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. For dead cases, the ICF can be waived after approved by IEC/IRB.
Key exclusion criteria
1. Have any other active malignancies.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Pauline |
| Middle name | |
| Last name | Ng |
Organization
Janssen Pharmaceutical K.K.
Division name
Oncology Dept., Medical Affairs Div.
Zip code
101-0065
Address
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
TEL
03-4411-7700
png16@its.jnj.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Tajima |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Operations Dept.
Zip code
101-0065
Address
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
TEL
03-4411-7700
Homepage URL
ytajima4@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Janssen Pharmaceutical K.K.
Address
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
Tel
03-4411-7700
ytajima4@its.jnj.com
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
| 2019 | Year | 06 | Month | 21 | 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
102
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation period: For 3-5 years from registration
Management information
Registered date
| 2019 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042307
