Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.: this researcher used a biodegradable material injection technique. after subdivision radical received radiation therapy We plan to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.
Study 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
Sex
MALE
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Prostate cancer patients confirmed histopathologically within 6 months prior to study enrollment
2. 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)
3. Adults over 20 years of age
4. Whole body performance ECOG 0-1
5. SpaceOAR Patients who consented to the procedure and the clinical study
Exclusion Criteria:
1. Prostatectomy, Patients with a history of lower pelvic surgery including rectal cancer surgery
2. primary cancer Patients with posterior extracapsular extension
3. Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate
4. Biodegradable material Patients who failed infusion
5. Patients with a history of previous pelvic radiation therapy
6. Patients with distant metastasis and intrapelvic lymph node metastasis
7. Patients who have undergone or are scheduled to undergo hormone therapy
Primary outcome measure(s)
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years — 5 years after radiation therapy of each participant NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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