UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060576 |
|---|---|
| Receipt number | R000069286 |
| Scientific Title | A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer |
| Date of disclosure of the study information | 2026/02/04 |
| Last modified on | 2026/02/04 12:08:44 |
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Basic information
Public title
A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer
Acronym
A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer
Scientific Title
A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer
Scientific Title:Acronym
A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
metastatic castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy of SPECT/CT images taken after LuPSMA treatment to assess treatment efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
radiographic progression free survival; rPFS
Key secondary outcomes
Overall survival from the start of LuPSMA treatment
Response assessment after completion of LuPSMA treatment (CR, PR, SD, PD)
Side effects assessment
Tumor marker changes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The study subjects are mCRPC patients who have undergone LuPSMA therapy. After admission to a dedicated treatment room, patients receive the prescribed dose of LuPSMA on the day of administration and are followed overnight by observation. The following day, once the dose is confirmed to be acceptable for discharge, images are taken using a SPECT/CT scan in our hospital's radioisotope (RI) laboratory to capture images of the lesion using gamma rays emitted by LuPSMA. This will be performed after the first six treatments to assess whether it is useful for assessing treatment efficacy. Conventional tumor markers and imaging tests (CT, MRI, bone scan) will be performed at standard intervals, and comparisons with these will also be conducted.
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) Adult men aged 20 years or older
(2) Patients pathologically diagnosed with prostate cancer
(3) Patients with mCRPC undergoing LuPSMA therapy at our hospital
(4) Patients who provide written informed consent to participate in this study
Key exclusion criteria
(1) Patients who do not consent to this study or who refuse to participate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
Gunma University Hospital
Division name
Department of Urology
Zip code
3718511
Address
3-39-22 Showa-Machi, Maebashi, Gunma JAPAN
TEL
0272208306
miya.yoshi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
Gunma University Hospital
Division name
Department of Urology
Zip code
3718511
Address
3-39-22 Showa-Machi, Maebashi, Gunma JAPAN
TEL
0272208306
Homepage URL
miya.yoshi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Yoshiyuki Miyazawa
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Committee
Address
3-39-15 Showa-Machi, Maebashi, Gunma JAPAN
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-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
| 2026 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2032 | 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
| 2026 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069286
