Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A single institution with a single group, a phase II study, low- and medium-risk studies performed after biodegradable substance injection prostate cancer dosage increase. The investigator plans to evaluate grade 1 or higher rectal bleeding occurring within 3 years in patients who have received low -fractionation curative radiotherapy.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 20
Healthy Volunteers: f
View:
• Prostate cancer patients confirmed histopathologically within 6 months prior to study enrollment
• Low-risk and medium- risk groups in terms of risk Prostate cancer patients (primary stage T2c or less, Grade group 3 or less, If PSA is less than 20ng/ml)
• Adults over 20 years of age
• Whole body performance ECOG 0-1
• SpaceOAR Patients who consented to the procedure and the clinical study
Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Won Park, M.D., Ph.D.
wonro.park@samsung.com
+82-2-3410-2616
Time Frame
Start Date: 2023-08-11
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 33
Treatments
Experimental: Prostate cancer patient, candidate of definitive radiation treatment
A single institution with a single group, a phase II study, Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center