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Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer

Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer - GUNMA1302

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000016646
Enrollment
280
Registered
2015-03-01
Start date
2013-07-01
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

Prostate cancer

Interventions

None listed

Sponsors

working group of heavy ion therapy for genitourinary tumor, Gunma university
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Histologically proven primary prostate adenocarcinoma 2) Gleason score is diagnosed 3) T1c-T3N0M0(2009, UICC 7th) 4) PSA value before biopsy is measured 5) Age at registration is 20-80 6) Performance status is 0-2 7) Diagnosis is informed 8) Having the ability to consent

Exclusion criteria

Exclusion criteria: 1) Past radiotherapy to the pelvic region 2) Past physical treatment of the prostate (TUR-P, HIFU, etc.) 3) Past chemotherapy within 4 weeks 4) Life expectancy is less than 6 months 5) Multiple malignancies within 5 years 6) Androgen deprivation therapy period will be over than 8 months at the end of carbon ion radiotherapy 7) Castration refractory 8) Denial for the protocol androgen deprivation therapy 9) Steroid and anti-androgen therapy for other disease 10) Severe comorbidity 11) Judged inappropriate for this study by physicians

Design outcomes

Primary

MeasureTime frame
5-yr biochemical relapse free survival

Secondary

MeasureTime frame
1) 5-yr overall survival 2) 5-yr cause specific survival 3) 5-yr local control 4) acute toxicity 5) late toxicity 6) QOL

Countries

Japan

Contacts

Public ContactHidemasa Kawamura

Gunma University Heavy ion medical center

kawa@gunma-u.ac.jp027-220-8378

Outcome results

None listed

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