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A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer

A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer - Radical carbon-ion radiotherapy using 4 fractions for prostate cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032340
Enrollment
60
Registered
2018-05-10
Start date
2018-05-13
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

Interventions

Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated in &quot
one-week&quot
groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed. Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated
two-weeks&quot
groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed.

Sponsors

Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) biopsy-proven prostate cancer 2) -T2cN0M0, PSA < 20 ng/ml, GS =<7 according to MRI, CT and bone scintigram 3) Performance Status (ECOG) of 0-1. 4) Expected prognosis > 6 months 5) Approved by document.

Exclusion criteria

Exclusion criteria: 1) Other therapies except for hormonal therapy 2) Previous radiation therapy to the pelvis 3) Ineligible dose constraints of risk organs 4) Castration resistant prostate cancer 5) Previous TUR-P 6) Active Double cancer 7) Presence of active double cancer

Design outcomes

Primary

MeasureTime frame
GI/GU adverse event

Secondary

MeasureTime frame
Biochemical failure free survival, overall survival, disease free survival, dose volume analysis, and evaluation of QOL

Countries

Japan

Contacts

Public ContactGoro Kasuya

QST Hospital , National Institutes for Quantum and Rad Treatment division

kasuya.goro@qst.go.jp043-206-3306

Outcome results

None listed

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