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A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer

A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer - A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011631
Enrollment
130
Registered
2013-09-03
Start date
2013-09-03
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 beam total dose 51.6 GyE 12 fractions

Sponsors

SAGA HIMAT foundation
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients of prostate cancer with pathollogical diagnosis 2) Patients with T1c-3N0M0 tumour accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition. 3) Perfomance status of the patient is from zero to two. 4) Life expectancy of the patients is longer than one year. 5) Regarding risk group and hormonal therapy, patients are matched following (a) or (b); (a) low risk patients have never received hormonal therapy, (b) intermediate patients and high risk patients received hormonal therapy longer than four months and shorter than eight months at the first day of the carbon-ion radiotherapy.

Exclusion criteria

Exclusion criteria: 1) Patients have received radiotherapy at the same position where carbon-ion radiotherapy is palanned. 2) Patients have received any kinds of therapies except hormonal therapy. 3) Patients have any other active malignancies. 4) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is palanned. 5) Patients with evidence of elevation of PSA after starting of hormonal therapy and before starting of carbon-ion radiotherapy.

Design outcomes

Secondary

MeasureTime frame
overall survival rate, cause-specific survival rate, normal tissue reaction, quality of life

Primary

MeasureTime frame
(biochemically or clinically) relapse free survival rate

Countries

Japan

Contacts

Public ContactToyama Shingo

SAGA HIMAT foundation Ion Beam Therapy Center

toyama-shingo@saga-himat.jp0942-81-1897

Outcome results

None listed

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