Clinical Trial: Prospective clinical trial of spacer-less and fiducials-less ultra-hypofractionated stereotactic body radiotherapy with concurrent administered Daikenchuto for prostate cancer (Japan)

Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062254) titled 'Prospective clinical trial of spacer-less and fiducials-less ultra-hypofractionated stereotactic body radiotherapy with concurrent administered Daikenchuto for prostate cancer' on Aug. 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Suita Tokushukai Hospital

Condition: Condition - Prostate cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - We prospectively investigate the efficacy of ultra-hypofractionated stereotactic body radiotherapy with concurrently administration of daikenchuto for patients with prostate cancer, without the implanted fiducials and rectal spacers. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Ultra-hypofractionated stereotactic body radiotherapy (36.25Gy in 5 fractions) with concurrently administration of Daikenchuto.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - 1) Patients eligible for Ultra-hypofractionated body radiotherapy (localized irradiation to the prostate + seminal vesicles) for prostate cancer (T1-T3aN0M0) 2) Male patients aged 20 years or older at the time of informed consent 3) Patients with an ECOG PS (Eastern cooperative oncology group performance status) score of 2 or less who are able to visit the outpatient clinic 4) Research subjects who have given their own free written consent after receiving sufficient explanation to participate in this research Key exclusion criteria - 1) Patients with a history of active multiple cancers 2) Patients who are suitable for radical intensity-modulated radiotherapy for prostate cancer, but who are judged to require combination therapy with pelvic irradiation due to pelvic lymph node metastases 3) Patient considered to be at high risk of urinary retention following radiation therapy due to an anatomically large prostate volume, resulting in the protrusion of the prostatic base into the bladder 4) Patients who have undergone pelvic radiation therapy before obtaining consent 5) Patients who are already known to be allergic to Daikenchuto and the herbal medicines contained in this drug 6) Patients who are unable to collect urine during radiotherapy due to co-morbidities such as hemodialysis 7) Patient with a history of transurethral resection of the prostate (TUR-P) for benign prostatic hyperplasia as a comorbid condition 8) Patients who are self-catheterized continuously in place due to urinary retention or severe urinary difficulty as a comorbidity 9) Patients with a history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as a comorbidity 10) Patients with persistent lower gastrointestinal bleeding symptoms due to hemorrhoids etc. as a comorbidity 11) Patients with interstitial pneumonia as a comorbidity 12) Patients with collagen disease as a comorbidity 13) Patients with severe renal disease (creatinine 2.0 mg/dl or more) 14)Other patients deemed unsuitable as research subjects by the research director Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 22 Day Date of IRB - 2026 Year 08 Month 09 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2034 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071234

Disclaimer: Curated by HT Syndication.