Status:
RECRUITING
Protons Vs. Photons for High-risk Prostate Cancer
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Prostate Cancer
Radiotherapy Side Effect
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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.
Detailed Description
Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients. Most PC patients treated with PT receive PT to the prostate gla...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2037
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05350475
Start Date
March 1 2022
End Date
March 1 2037
Last Update
March 7 2025
Active Locations (7)
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1
Dept. of Oncology, Rigshospitalet, Denmark
Copenhagen, Capital Region, Denmark
2
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, Capital Region, Denmark, DK-2730 Herlev
3
Department of Oncology, Aarhus University Hospital
Aarhus, Central Region, Denmark, 8200
4
Dept. of Oncology, Aalborg University Hospital
Aalborg, Region North, Denmark