Actively Recruiting

Phase 2
Age: 20Years +
MALE
NCT06461793

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)

Led by Samsung Medical Center · Updated on 2024-06-21

33

Participants Needed

1

Research Sites

537 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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)

Who Can Participate

Age: 20Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
  • Patients with high-risk prostate cancer (cT3a-T4 or grade group 4-5 or PSA > 20 ng/mL)
  • Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer
  • Adults over 20 years of age
  • Whole body performance status ECOG 0-1
  • Patients who consented to the SpaceOAR procedure and study
Not Eligible

You will not qualify if you...

  • History of prostate removal surgery or lower pelvic surgery including rectal cancer surgery
  • Presence of primary cancer with posterior extracapsular extension
  • Medically unsuitable for infusion of biodegradable substances due to bleeding risk
  • History of previous pelvic radiation therapy
  • Presence of lymph node metastasis or distant metastasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

W

Won Park, M.D., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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