臨床研究等提出・公開システム

Date of registration	June. 16, 2026
Last modified on	June. 16, 2026
Trial ID	jRCT1020260017

Scientific Title	Prospective Observational Study for Identification of Predictive Biomarkers of PSMA-Targeted Radioligand Therapy in Prostate Cancer (PROBE-PSMA study)
Public Title	Study of Predictive Biomarkers for Response to PSMA Radioligand Therapy in Prostate Cancer (PROBE-PSMA study)

Contact for Scientific Queries	Name	Hoshi Seiji
	Affiliation	Department of Urology, Fukushima Medical University Hospital, Fukushima, Japan
	Address	1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1111
	E-mail	uro-hosi@fmu.ac.jp
Contact for Public Queries	Name	Yaginuma Kei
	Affiliation	Department of Urology, Fukushima Medical University Hospital, Fukushima, Japan
	Address	1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1111
	E-mail	uro-yagi@fmu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 16, 2026
Actual date of first enrollment		June. 22, 2026
Target sample size		450
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Histologically or clinically diagnosed prostate cancer. 2. Planned to initiate PSMA radioligand therapy or other standard systemic therapy. 3. Undergoing blood sampling and imaging assessments as part of routine clinical practice. 4. Able to provide written informed consent. 5. Able to comply with study follow-up.
	Exclusion Criteria	1. Considered unsuitable for study participation by the treating physician. 2. Unable to provide informed consent. 3. Medically unable to undergo blood sampling or study follow-up. 4. Considered unsuitable by the principal investigator for safety or study conduct reasons.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Castration resistant prostate cancer
Health Condition(s) Keyword		prostate cancer, PSMA
Health Condition(s) Code		C537243
Primary Outcome(s)		Exploration of biomarkers predictive of progression-free survival (PCWG-PFS) based on the Prostate Cancer Working Group 3 (PCWG3) criteria.

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Research Ethics Committee of Fukushima Medical University
Address	1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmurec@fmu.ac.jp
Approval Status	Approval
Date of approval	June. 15, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none