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)

Recruiting now · Phase 2

Conditions studied: High Risk Prostate Carcinoma

In brief

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

Key facts

Study ID

NCT06461793

Run by

Samsung Medical Center

People needed

33

Starts

2023-09-12

Expected to finish

2033-12-31

Last updated by the study team

2024-06-21

Who can join

Age: 20 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Samsung Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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