Clinical trial · Interventional
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer (DESAR-H)
NCT06461793CI-TRIAL-00078121DESAR-HrecruitingPhase 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)
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy
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 |
|---|---|---|---|
| High Risk Prostate Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients | 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, we plan to evaluate grade 1 or higher rectal bleeding within 3 years in high-risk prostate cancer patients who received biodegradable substance injection followed by curative radiotherapy in combination with hormone therapy.
- interventionNames
- Radiation: Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
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
- 3 years after radiation therapy of each participant
- description
- Adverse Event within three years after the radiation therapy
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment 2. Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA \> 20 n g/mL) ) 3. Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer 4. Adults over 20 years of age 5. Whole body performance ECOG 0-1 6. SpaceOAR Patients who consented to the procedure and study Exclusion Criteria: 1. prostate removal surgery, 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. Patients with a history of previous pelvic radiation therapy 5. Patients with lymph node metastasis or distant metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.