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
Phase 2Interventional Study
Low-to-intermediate-risk Prostate Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
Samsung Medical Center · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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 yea…
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
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