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)

About This Trial

This study is testing whether giving higher doses of radiation over fewer total visits, alongside hormone therapy, is safe and effective for treating prostate cancer.
To help protect nearby healthy organs from radiation damage, doctors will first insert a temporary, dissolvable gel spacer between the prostate and the rectum.
The trial is open to adults with high-risk prostate cancer that has not spread to the lymph nodes or other parts of the body.
Before considering this study, patients should know that it requires a minor procedure to place the protective gel, and it is not suitable for those who have previously had radiation or surgery in the pelvic area.

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

Age Range: 20 years and older
Gender: Male
Who This Trial is For: This study is testing whether giving higher doses of radiation over fewer total visits, alongside hormone therapy, is safe and effective for treating prostate cancer.

Full Eligibility Criteria

Inclusion Criteria

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 Criteria

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