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 · NCT06461793 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
What this trial is about
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
Who can take part
Age range
20 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea