臨床研究等提出・公開システム

Date of registration	July. 09, 2025
Last modified on	Oct. 22, 2025
Trial ID	jRCT2031250225

Scientific Title	A Phase 2, Multicenter, Open-label study to Test the Diagnostic Performance of 64Cu-PSMA-I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection in Japan
Public Title	A Phase 2 study of 64Cu-PSMA-I&T with Prostate Cancer Patients

Contact for Scientific Queries	Name	Masuda Ryohei
	Affiliation	PDRadiopharma Inc.
	Address	2-14-1, Kyobashi,Chuo-ku, Tokyo
	Telephone	+81-3-6263-0454
	E-mail	s-clinicaltrial-info@pdradiopharma.com
Contact for Public Queries	Name	Miki Satoshi
	Affiliation	PDRadiopharma Inc.
	Address	2-14-1, Kyobashi,Chuo-ku, Tokyo
	Telephone	+81-3-6263-0454
	E-mail	s-clinicaltrial-info@pdradiopharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 10, 2025
Actual date of first enrollment		Sept. 18, 2025
Target sample size		70
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with histologically proven prostate adenocarcinoma. 2. Planned prostatectomy with pelvic lymph node dissection. 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
	Exclusion Criteria	1. Patients who have received androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any treatment under development for prostate adenocarcinoma. 2. Patients participating in other clinical trials within 90 days prior to the date of consent. 3. Patients who are planned to have an x-ray contrast within 24 hours or other PET scan with other tracers within 24 hours prior to administration of R-241B. If Barium contrast is administered this should be cleared before the PET scan. 4. Patients who have received radiopharmaceuticals labeled with 131I within 60 days prior to administration of R-241B. 5. Patients who are allergic to any of the active ingredients or additives of the investigational drug. 6. Male patients with a female partner of childbearing potential who cannot agree to use contraception for 1 week after R-241B administration.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Prostate Cancer
Intervention(s)		A single intravenous dose of 296 MBq (10%) of R-241B will be administered to patients with poor prognosis intermediate-risk, high-risk or very high-risk first prostate cancer who are scheduled for prostatectomy with pelvic lymph node dissection.
Primary Outcome(s)		Sensitivity and specificity of PET/CT with R-241B for pathologically confirmed positive pelvic lymph nodes
Secondary Outcome(s)		Efficacy: Inter-reader agreement for subject-specific reading results of R-241B PET/CT, read in an independent, blinded fashion Safety: adverse events, clinical test, vital signs, 12-lead ECG and self-assessment findings

Primary Sponsor	PDRadiopharma Inc.

Name of Certified Review Board	Institute of Science Tokyo Hospital Institutional Review Board
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Telephone	+81-3-5803-4575
E-Mail	Tiken.crc@tmd.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Keio University Hospital Institutional Review Board
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Telephone	+81-3-3353-1211
E-Mail	Keio-chiken@adst.keio.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Kyushu University Hospital Institutional Review Board
Address	3-1-1 Maidashi, Higashi-ku, Tokyo
Telephone	+81-92-642-5577
E-Mail	rinri@med.kyushu-u.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Kobe University Hospital Institutional Review Board
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Tokyo
Telephone	+81-78-382-6724
E-Mail	irb-office@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Osaka University Hospital Institutional Review Board
Address	2-15 Yamadaoka, Suita-shi, Tokyo
Telephone	+81-6-6210-8290
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Institutional Review Board , Kanazawa University Hospital
Address	13-1 Takaramachi, Kanazawa-shi, Tokyo
Telephone	+81-73-265-2090
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita 14, Nishi 5, Kita-ku, Sapporo-shi, Tokyo
Telephone	+81-11-706-7084
E-Mail	crmic@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Institutional Review Board, Tokyo Medical University Hospital
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
Telephone	+81-3-3342-6111
E-Mail	irb@tokyo-med.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Telephone	+81-3-3822-2131
E-Mail	tokutei-nmshp.group@nms.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Institutional Review Board, Chiba University Hospital
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Tokyo
Telephone	+81-43-222-7171
Approval Status	Approval
Date of approval	July. 10, 2025

Name of Certified Review Board	Joint Institutional Review Board of Fujita Health University Hospital Group
Address	1-98 Dengakugakubo, Kutsukakecho, Toyoake-shi, Tokyo
Telephone	+81-562-93-2873
E-Mail	gcpjim@fujita-hu.ac.jp
Date of approval	July. 10, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Oct. 22, 2025	(this page)	Changes
4	Sept. 10, 2025	Detail	Changes
3	July. 09, 2025	Detail	Changes
2	July. 09, 2025	Detail	Changes
1	July. 09, 2025	Detail

List of change history