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A Phase I/II trial of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy

A Phase I/II trial of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy - Carbon-ion radiotherapy for local recurrence prostate cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028630
Enrollment
20
Registered
2017-08-29
Start date
2017-08-24
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

Carbon-ion radiotherapy of 40Gy(RBE)in 4 fraction within 1 week.

Sponsors

QST Hospital, National Institutes for Quantum Science and Technology Treatment division
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Local recurrence biopsy proven prostate cancer after radical radiotherapy. 2) rT2a-T2bN0M0 according to MRI, CT and bone scintigram (visible lesion in MRI). 3) PSA < 8.0 ng/ml before biopsy proven local recurrence after biochemical relapse. 4) PSA doubling time > 6 months. 5) Teststeron value within 30 days before starting this treatment > within normal lower limit. 6) Performance Status (ECOG) of 0-1. 7) Approved by document.

Exclusion criteria

Exclusion criteria: 1) Other salvage therapy has been performed except for the case with positive local recurrence by biopsy after discontinuance of hormonal therapy 2) Presence of biopsy proven separate lesions except for visible lesion in MRI. 3) Having at least one factor of GS>9, T3b and PSA > 40 ng/ml before initial radical radiotherapy. 4) occuring Grade 3 or more severe adverse effect after initial radical radiotherapy. 5) Ineligible dose constraint of risk organs 6) Considered to be castration resistant prostate cancer 7) Presence of active double cancer

Design outcomes

Primary

MeasureTime frame
Acute and late adverse effect

Secondary

MeasureTime frame
Biochemical relapse free survival, overall survival, Clinical relapse free survival, cancer specific survival, dose-volume evaluation, QOL evaluation

Countries

Japan

Contacts

Public ContactGoro Kasuya

QST Hospital, National Institutes for Quantum Science and Technology Treatment division

kasuya.goro@qst.go.jp043-251-2111

Outcome results

None listed

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