4fr.CIRT for high risk-prostate cancer + dose measurement

JRCT ID: jRCTs032190180

Registered date:09/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 07/04/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy

Outcome(s)

• Primary Outcome: Adverse event
• Secondary Outcome: Biochemical failure free survival rate, Overall survival rate, Non-clinical recurrence rate, Cancer specific survival rate, Evaluation of dose-volume histogram, evaluation of QOL, urethral dose evaluation by using of dosimeter

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male
• Include criteria: 1) biopsy-proven prostate cancer, 2) age >20 years, 3) T3a-T4N0M0 or PSA >= 20 ng/ml, GS>=8 according to MRI, CT and bone scintigram 4) Performance Status (ECOG), 0-1 5) Expected prognosis > 6 months 6) ability to understand and sign an informed consent form at each institution.

Exclude criteria

1) Other therapies except for hormonal therapy
2) Previous radiation therapy to the pelvis
3) Significant excess over the dose-constraints for risk organs
4) Castration-resistant prostate cancer
5) Previous treatment history of TUR-P
6) Active Double cancer
7) Untreatable infection or inflammatory disease in pelvis.
8) a serious medical or psychological condition precluding safe administration of treatment

Related Information

• Primary Sponsor: Tsuji Hiroshi