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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Proton therapy
RadiationPatients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.
Photon therapy
RadiationPatients in the photon arm will receive standard treatment with photon therapy.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Proton therapyExperimental treatment 1 intervention
Group B: Photon TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinically significant, measured by mean points, which is considered clinically significant.
Time frame
2 yearsSecondary outcomes
1
Late Genito-urinary (GU) and sexual toxicity ≥ 2 grade at year 2 and 5 compared to baseline (Common Terminology Criteria for Adverse Events (CTCAE) toxicity score (CTC_AE 5.0)
Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0
Time frame
5 years2
Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)
Patient Reported Outcome using on-line questionnaire to assess this outcome measure
Time frame
10 years3
Late GI toxicity at year 5 compared to baseline (EPIC-26)
Patient Reported Outcome using on-line questionnaire to assess this outcome measure.aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinically significant, measured by mean points, which is considered clinically significant
Time frame
5 years4
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
EPIC-26
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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