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Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
RECRUITINGPhase 2Sponsored by Samsung Medical Center
Actively Recruiting
PhasePhase 2
SponsorSamsung Medical Center
Started2023-08-11
Est. completion2033-12-31
Eligibility
Age20 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06461819
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
Age: 20 Years+Sex: MALEHealthy volunteers accepted
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
Conditions2
CancerLow-to-intermediate-risk Prostate Carcinoma
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Actively Recruiting
PhasePhase 2
SponsorSamsung Medical Center
Started2023-08-11
Est. completion2033-12-31
Eligibility
Age20 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06461819