A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer

A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer - A Prospective Observational Study on the Carbon Ion Therapy for Advanced Prostate Cancer (iROCK-PR01 Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020354

Enrollment

Registered

2015-12-28

Start date

2015-11-01

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 or locally advanced prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Histologically proven primary prostate adenocarcinoma 2) cT1c,T2a,T2b,T2c,T3a,T3bN0M0 (2009, UICC 7th) 3) Performance status is 0, 1 or 2 4) Under 20 years old of age at registration 5) Untreated patient in 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) Past history of radiotherapy in the irradiation lesion concerned 2) Multiple active malignancies 3) Medically or psychologically inappropriate status for this study judged by physicians

Design outcomes

Primary

Measure	Time frame
Incidence of late-phase rectal adverse event with CTCAE Grade 2 or more	—

Secondary

Measure	Time frame
1) Incidence of early and late adverse events 2) 5-year biochemical and clinical recurrence 3) 5-year overall survival 4) Local control rate 5) ECOG Performance Status (PS)	—

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