RecruitingPhase 2NCT06461793

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)


Sponsor

Samsung Medical Center

Enrollment

33 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a higher dose of radiation therapy (hypofractionated radiotherapy — meaning fewer, larger doses) is safe for men with high-risk localized prostate cancer, using a gel spacer (SpaceOAR) to protect the rectum from radiation damage. **You may be eligible if...** - You are a man aged 20 or older with prostate cancer confirmed by biopsy within the past 6 months - Your cancer is classified as high-risk (stage T3a–T4, Gleason Grade Group 4–5, or PSA over 20) - You have received or are planned to receive hormone therapy for your prostate cancer - You have had or are willing to have the SpaceOAR gel spacer procedure - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have had previous prostate removal surgery or other lower pelvic surgery (including rectal cancer surgery) - You have already had pelvic radiation therapy - You have lymph node or distant metastases - You have a bleeding disorder or other condition preventing the gel spacer infusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDose 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.


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT06461793


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