Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05804318

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Led by Varian, a Siemens Healthineers Company · Updated on 2026-02-05

132

Participants Needed

7

Research Sites

428 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.

CONDITIONS

Official Title

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Biopsy-proven low or intermediate risk prostate cancer as defined by NCCN
  • Prostate volume less than or equal to 80cc as measured by MRI before radiotherapy
  • AUA/IPSS urinary symptom score of 15 or less
  • ECOG performance status of 2 or less (or Karnofsky score of 60% or higher)
  • No PIRADS 4 or 5 lesion on prostate MRI contacting the urethra, as determined by physician
  • Ability to complete required patient questionnaires
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Baseline grade 3 or higher gastrointestinal or genitourinary toxicity
  • Prior overlapping pelvic radiotherapy
  • History of transurethral resection of the prostate, prostate HIFU, or cryoablation
  • Node positive prostate cancer
  • Presence of extracapsular extension (capsular abutment is allowed)
  • Active inflammatory bowel disease or active collagen vascular disease
  • Inability to undergo prostate MRI
  • Inability to undergo prostate fiducial marker placement
  • Currently receiving cytotoxic chemotherapy (androgen deprivation therapy is allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Duarte Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

2

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States, 92618

Actively Recruiting

3

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Active, Not Recruiting

4

Washington University in St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

5

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Active, Not Recruiting

6

Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)

Homburg, Saarland, Germany, 66421

Actively Recruiting

7

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

S

Sean Davidson, MASc

CONTACT

C

Claire McCann, PhD

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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Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer | DecenTrialz