Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05350475

Protons Vs. Photons for High-risk Prostate Cancer

Led by University of Aarhus · Updated on 2025-03-07

400

Participants Needed

7

Research Sites

782 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.

CONDITIONS

Official Title

Protons Vs. Photons for High-risk Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically verified localized or locally advanced prostate cancer T1-3bN0-1M0 (clinical T4 allowed if due to bladder neck invasion)
  • Adenocarcinoma with at least 50% adenocarcinoma component
  • Indication for elective lymph node irradiation
  • PSA less than 100 ng/mL
  • Age 18 years or older
  • Performance status of 0-1
  • Life expectancy of 10 years or more
  • Able to understand and comply with the treatment protocol
  • No evidence of inflammatory bowel disease
  • Able to adhere to study and follow-up procedures
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Previous treatment for prostate cancer
  • Presence of hip prostheses
  • Other metal devices in the pelvic region except fiducials
  • Previous major abdominal or rectal surgery
  • Any other malignancy in the last five years except basal or squamous cell skin cancer
  • Unable to understand patient information or comply with treatment and safety instructions
  • Unable to read and understand patient information due to cognitive disabilities or language barriers (Danish)

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

Dept. of Oncology, Rigshospitalet, Denmark

Copenhagen, Capital Region, Denmark

Not Yet Recruiting

2

Department of Oncology, Copenhagen University Hospital Herlev

Herlev, Capital Region, Denmark, DK-2730 Herlev

Actively Recruiting

3

Department of Oncology, Aarhus University Hospital

Aarhus, Central Region, Denmark, 8200

Actively Recruiting

4

Dept. of Oncology, Aalborg University Hospital

Aalborg, Region North, Denmark

Actively Recruiting

5

Dept. of Oncology, Zealand University Hospital, Denmark

Næstved, Region Sjælland, Denmark

Actively Recruiting

6

Department of Oncology, Odense University Hospital

Odense, Region South, Denmark, 5000

Not Yet Recruiting

7

Department of Oncology, Vejle Hospital, Denmark

Vejle, Region South, Denmark

Actively Recruiting

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Research Team

S

Stine Elleberg Petersen, MD, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Protons Vs. Photons for High-risk Prostate Cancer | DecenTrialz