Recruiting
Phase 2
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 study
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
- Condition
- High Risk Prostate Carcinoma
- Tested
- Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
- Sponsor
- Samsung Medical Center
Who can join
- Age
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 20 years
- Eligible sex: Male
- Study condition: High Risk Prostate Carcinoma
- 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 5
- 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
1 site, 1 recruiting
Samsung Medical Center
Seoul, South Korea
Contact
-
Won Park, M.D., Ph.D.
+82-2-3410-2616 wonro.park@samsung.com
Potential match only. Final eligibility is determined by the study team.