Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
Recruiting · NCT06461819 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
What this trial is about
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.
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
- 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
Exclusion criteria
- Prostatectomy, 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
- Biodegradable material Patients who failed infusion
- Patients with a history of previous pelvic radiation therapy
- Patients with distant metastasis and intrapelvic lymph node metastasis
- Patients who have undergone or are scheduled to undergo hormone therapy
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea