RecruitingPhase 2NCT06461793

Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer (DESAR-H)

Sponsor

Samsung Medical Center

Enrollment

33 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

High Risk Prostate Carcinoma

Summary

Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy

Eligibility

Sex: MALEMin Age: 20 Years

Inclusion Criteria6

Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA \> 20 n g/mL) )
Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer
Adults over 20 years of age
Whole body performance ECOG 0-1
SpaceOAR Patients who consented to the procedure and study

Exclusion Criteria5

prostate removal surgery, Patients with a history of lower pelvic surgery including rectal cancer surgery
primary cancer Patients with posterior extracapsular extension
Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate
Patients with a history of previous pelvic radiation therapy
Patients with lymph node metastasis or distant metastasis

Interventions

RADIATIONDose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients

this researcher performed biodegradable material injection during radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. after subdivision radical received radiation therapy We plan to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.

Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT06461793

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