JPRN-jRCT1030220062
Recruiting
Phase 1
Phase I study of stereotactic body radiotherapy as postoperative adjuvant or salvage therapy for prostate cancer
Yamashita Hideomi0 sites36 target enrollmentMay 11, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yamashita Hideomi
- Enrollment
- 36
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Patients who undergo radical prostatectomy at our hospital for prostate cancer and will receive radiation therapy as adjuvant or salvage therapy at our hospital.
- •b) Performance status (PS): 0\-2\.
- •c) Over 18 years old.
- •d) Patients whose pre\-registration treatment plan meets the dose constraints.
- •e) A blood test within 28 days prior to the start of radiation therapy meets all of the following:
- •WBC \> 3,000 /mm3
- •Hb \> 10\.0 g/dL
- •Plt \> 75,000 /mm3
- •eGFR \> 60 mL/min/1\.73 m2
- •f) Patients who has given written consent to participate in the study.
Exclusion Criteria
- •a) Patients who did not consent to participate in the study.
- •b) With lymph node metastasis or distant metastasis.
- •c) With a history of radiation therapy to the pelvis.
- •d) With inflammatory bowel disease such as ulcerative colitis and Crohn's disease.
- •e) With a history of rectal surgery.
- •f) Patients participating in other clinical trials that may affect the conduct or outcome of this study.
- •g) Patients who are judged to be inappropriate to participate in this study by the principal investigater or co\-investigaters.
Outcomes
Primary Outcomes
Not specified
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