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Hypofractionated proton beam therapy for localized prostate cancer

Hypofractionated proton beam therapy for localized prostate cancer - Hypofractionated proton beam therapy for localized prostate cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020199
Enrollment
120
Registered
2015-12-15
Start date
2015-12-15
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

Prostate cancer

Interventions

67.5GyE in 25 fractions with a fractional dose of 2.7Gy

Sponsors

Aizawa hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Pathologically proven adenocarcinoma of the prostate 2) cT1c-T4N0M0(UICC 7th) Prostate cancer 3) ECOG-PS 0-2 4) Age 20-yrs old or over at the time of consent form is obtained 5) Well informed and documented consent from the patient

Exclusion criteria

Exclusion criteria: 1) With active other cancers 2) With severe uncontrolled diabetes 3) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 4) Allergic to radiation 5) Previous surgical treatment for prostate disease before enrollment 6) Previous chemotherapy (except holmonal therapy)for prostate cancer before enrollment 7) Previous radiotherapy to pelvis 8) With implantable cardioverter defibrillator or permanent pacemaker 9) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 10) Cannot be held rest for about 60 minutes 11) Cannot be implanted Au marker in the prostate 12) Unsuitable for enrollment judged by principal investigator

Design outcomes

Primary

MeasureTime frame
5-year rate of Grade 2 or worse late toxicity

Secondary

MeasureTime frame
Acute and late toxicity rate, biochemical relapse-free rate, overall survival rate, cause-specific survival rate, and clinical relapse-free survival rate at 5 years

Countries

Japan

Contacts

Public ContactMasayuki Araya

Aizawa hospital Proton therapy center

ai.65718@ai-hosp.or.jp+81-263-33-8600

Outcome results

None listed

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