Actively Recruiting

Phase 2
Age: 20Years +
MALE
NCT06461819

Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)

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

33

Participants Needed

1

Research Sites

542 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)

Who Can Participate

Age: 20Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Prostate cancer confirmed by tissue diagnosis within 6 months before enrollment
  • Low- or medium-risk prostate cancer (stage T2c or less, grade group 3 or less, PSA below 20 ng/ml)
  • Age 20 years or older
  • ECOG performance status 0 or 1
  • Consent to SpaceOAR procedure and clinical study participation
Not Eligible

You will not qualify if you...

  • History of prostatectomy or lower pelvic surgery including rectal cancer surgery
  • Presence of primary cancer with posterior extracapsular extension
  • Medical conditions making biodegradable substance infusion unsafe, such as bleeding risk
  • Failure of biodegradable material infusion
  • Previous pelvic radiation therapy
  • Distant metastasis or intrapelvic lymph node metastasis
  • Current or planned hormone therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here