A Prospective Clinical Trial of Proton Radiotherapy with 8 fractions for Patients with Prostate Cancer

UMIN ID: UMIN000055899

Registered date:22/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2024/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 44GyRBE in 8 fractions with a fractional dose of 5.5GyRBE (3 or 4 times per week)

Outcome(s)

• Primary Outcome: Early-phase (< 90 days after start of irradiation) bladder/urinary adverse event rate (>Grade 2)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude 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 such as high degree of prostatic hyperplasia

Related Information

• Primary Sponsor: Narita Memorial Proton Center
• Source(s) of Monetary Support: None