Proton therapy: Patients 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: Patients in the photon arm will receive standard treatment with photon therapy.
Study summary
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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* Age ≥18 years
* Performance status 0-1
* Life expectancy ≥ 10 years
* Able to understand and comply with the treatment protocol
* No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
* Signed informed consent to participate in the study
Exclusion Criteria:
* No previous treatment for prostate cancer
* Hip-prostheses
* Other metal devices in the pelvic region (except fiducials)
* Previous major abdominal/rectal surgery
* Any other malignancy the last five years except for 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 (Danish).
Primary outcome measure(s)
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) — 2 years Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 10 points, which is considered clinically significant.
Trial sites (7)
Facility
City
Region
Status
Dept. of Oncology, Rigshospitalet, Denmark
Copenhagen
Capital Region
Department of Oncology, Copenhagen University Hospital Herlev
Herlev
Capital Region
Department of Oncology, Aarhus University Hospital
Aarhus
Central Region
Dept. of Oncology, Aalborg University Hospital
Aalborg
Region North
Dept. of Oncology, Zealand University Hospital, Denmark
Næstved
Region Sjælland
Department of Oncology, Odense University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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