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4fr.CIRT for high risk-prostate cancer + dose measurement

A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with high-risk prostate cancer and urethral dose measurement

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032190180
Enrollment
40
Registered
2020-01-09
Start date
2020-04-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Prostate cancer

Interventions

Sponsors

Tsuji Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) biopsy-proven prostate cancer, 2) age >20 years, 3) T3a-T4N0M0 or PSA >= 20 ng/ml, GS>=8 according to MRI, CT and bone scintigram 4) Performance Status (ECOG), 0-1 5) Expected prognosis > 6 months 6) ability to understand and sign an informed consent form at each institution.

Exclusion criteria

Exclusion criteria: 1) Other therapies except for hormonal therapy 2) Previous radiation therapy to the pelvis 3) Significant excess over the dose-constraints for risk organs 4) Castration-resistant prostate cancer 5) Previous treatment history of TUR-P 6) Active Double cancer 7) Untreatable infection or inflammatory disease in pelvis. 8) a serious medical or psychological condition precluding safe administration of treatment

Design outcomes

Primary

MeasureTime frame
Adverse event

Secondary

MeasureTime frame
Biochemical failure free survival rate, Overall survival rate, Non-clinical recurrence rate, Cancer specific survival rate, Evaluation of dose-volume histogram, evaluation of QOL, urethral dose evaluation by using of dosimeter

Contacts

Public ContactHiroshi Tsuji

QST hospital, National Institutes for Quantum Science and Technology

tsuji.hiroshi@qst.go.jp+81-43-206-3306

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026