Actively Recruiting
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
Eligibility Criteria
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
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
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
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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