Protons Vs. Photons for High-risk Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer, Radiotherapy Side Effect

In brief

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.

Key facts

Study ID

NCT05350475

Run by

University of Aarhus

People needed

400

Starts

2022-03-01

Expected to finish

2037-03-01

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Dept. of Oncology, Aalborg University Hospital — Aalborg, Region North, Denmark (enrolling)
• Department of Oncology, Copenhagen University Hospital Herlev — Herlev, Capital Region, Denmark (enrolling)
• Department of Oncology, Aarhus University Hospital — Aarhus, Central Region, Denmark (enrolling)
• Dept. of Oncology, Zealand University Hospital, Denmark — Næstved, Region Sjælland, Denmark (enrolling)
• Department of Oncology, Vejle Hospital, Denmark — Vejle, Region South, Denmark (enrolling)
• Dept. of Oncology, Rigshospitalet, Denmark — Copenhagen, Capital Region, Denmark
• Department of Oncology, Odense University Hospital — Odense, Region South, Denmark

Full record on ClinicalTrials.gov

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