Protons Vs. Photons for High-risk Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
Qualifiers
Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
Indication for elective lymph node irradiation
PSA < 100 ng/mL
Disqualifiers
No previous treatment for prostate cancer
Hip-prostheses
Other metal devices in the pelvic region (except fiducials)
Previous major abdominal/rectal surgery
Trial design
Treatments tested in this trial
- Proton therapy
- Photon therapy
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Odense University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Sygehus Lillebaelt
Collaborator
Herlev and Gentofte Hospital
Collaborator
Naestved Hospital
Collaborator
Source ClinicalTrials.gov