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)

NCT06461793 · tracked via the Priya Life Science South Korea tracker

Sponsor

Samsung Medical Center

Phase

Phase 2

Started

2023-09-12

Last updated

2024-06-21

Condition(s) studied

High Risk Prostate Carcinoma

Investigational drug(s) / intervention(s)

Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients

Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients: this researcher performed biodegradable material injection during radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. 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

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

Eligibility

Sex

MALE

Min age

20 Years

Max age

—

Healthy volunteers

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

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 — 3 years after radiation therapy of each participant
Adverse Event within three years after the radiation therapy

Trial sites (1)

Facility	City	Region	Status
Samsung Medical Center	Seoul	South Korea	Recruiting

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Official registry record

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.

View NCT06461793 on ClinicalTrials.gov ↗ ← All trials in South Korea