Phase I study of postoperative stereotactic body radiotherapy for prostate cancer

Phase 1

Recruiting

• Conditions: prostate cancer; D011471

• Registration Number: JPRN-jRCT1030220062
• Lead Sponsor: Yamashita Hideomi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified