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Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer

Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer - Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038279
Enrollment
300
Registered
2020-01-06
Start date
2020-01-06
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

Nagoya City University West Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically-confirmed prostate cancer 2) T1-T3bN0M0 3) ECOG-PS: 0-2 4) age: more than 20 years old 5) serious underlying disease or other cancers 6) capable of maintaining their position during irradiation 7) technically capable of proton therapy 8) written informed consent

Exclusion criteria

Exclusion criteria: 1)pathological specimen is not available to confirm the diagnosis 2)previous radiotherapy around the lesion 3)surgery for prostate cancer is performed prior to registration 4)active and uncontrolled infection 5)two or more anticoagulants and antiplatelets 6)bowel disease such as ulcerative colitis or postoperative rectal cancer 7)patients who cannot or refuse gold markers and Space OAR 8)serious complication 9)cases in which the doctor is judged inappropriate for medical or other reasons

Design outcomes

Primary

MeasureTime frame
The ratio of grade 2 or more acute genitourinary toxicity

Secondary

MeasureTime frame
5-year OS, bRFS, cRFS, bRF, cRF, Grade 2 or more late toxicity, QOL change

Countries

Japan

Contacts

Public ContactHiromitsu Iwata

Nagoya City University West Medical Center,Nagoya Proton Therapy Center Radiation oncology

h-iwa-ncu@nifty.com052-991-8577

Outcome results

None listed

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