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A Prospective Clinical Trial of Proton Radiotherapy with 12 fractions for Patients with Prostate Cancer

A Prospective Clinical Trial of Proton Radiotherapy with 12 fractions for Patients with Prostate Cancer - Proton Radiotherapy with 12 fractions for Prostate Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045064
Enrollment
200
Registered
2021-08-16
Start date
2021-09-01
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

51.6GyRBE in 12 fractions with a fractional dose of 4.3GyRBE (4 times per week)

Sponsors

Narita Memorial Proton Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed primary prostate adenocarcinoma 2) Either clinical stage of T1-T3b and N0M0, in accordance with UICC (2017) 3) ECOG Performance status is 0, 1 or 2 4) Twenty years old of age at registration or more 5) Patient without active double cancer or severe basic disease 6) Patient who can keep his posture during irradiation 7) Technically being able to be irradiated 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patient without tissue specimen of biopsy 2) Patient with past history of radiotherapy for the targeted lesion 3) Patient with past history of surgery for the target lesion 4) Patient with active and intractable infection in the targeted lesion 5) Patient who is administrated more than two anticoagulant drugs 6) Inflammatory bowel diseases or after the surgery of rectal cancer 7) Patient who cannot be put the metal marker or spacer 8) Patient with severe disease 9) Judged as inappropriate to participation by investigators

Design outcomes

Primary

MeasureTime frame
Early-phase (< 90 days after start of irradiation) bladder/urinary adverse event rate (>Grade 2)

Countries

Japan

Contacts

Public ContactTakeshi Yanagi

Narita memorial proton center Department of proton

tyana116@meiyokai.or.jp0532-33-0033

Outcome results

None listed

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