Clinical trial · Interventional
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
NCT06461819CI-TRIAL-00078140DESAR-LrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-to-intermediate-risk Prostate Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate cancer patient, candidate of definitive radiation treatment
- description
- 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.
- interventionNames
- Radiation: Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
Primary outcomes (1)
- measure
- NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years
- timeFrame
- 5 years after radiation therapy of each participant
- description
- NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.