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Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer

Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer - Extended Study of Carbon-Ion Radiotherapy for Prostate Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021517
Enrollment
145
Registered
2016-03-18
Start date
2016-03-15
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

Localized prostate cancer

Interventions

Sponsors

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed primary prostate adenocarcinoma 2) Clinical stage of T1b, T1c, T2a, T2b, T2c, T3a or T3b and N0 M0, in accordance with UICC 7th (2009) 3) ECOG Performance status is 0, 1 or 2 4) Twenty years or older of the age at registration 5) Untreated patient for prostate cancer, excluding neoadjuvant endocrine therapy 6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy

Exclusion criteria

Exclusion criteria: 1) Patient with past history of radiotherapy for the targeted lesion 2) Patient with active double cancer 3) Patient with hormone-resistant prostate cancer 4) Patients with active and intractable infection in the targeted lesion 5) Patient with metal devices in the lesion 6) Other medical or psychological condition which is unsuitable for carbon-ion therapy

Design outcomes

Primary

MeasureTime frame
Biochemical progression-free survival at 5 years

Secondary

MeasureTime frame
1) Overall survival, Disease-specific survival 2) Local recurrence-free survival 3) Early and late-phase adverse event rate

Countries

Japan

Contacts

Public ContactHiroyuki Katoh

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center

hkatoh@kcch.jp045-520-2222

Outcome results

None listed

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