Protons Vs. Photons for High-risk Prostate Cancer

Launched by UNIVERSITY OF AARHUS · Apr 21, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of two types of radiation therapy—proton therapy and photon therapy—on men with high-risk prostate cancer. The main goal is to see which treatment causes fewer long-term gastrointestinal side effects, such as issues with digestion or bowel movements, after patients receive radiation to the whole pelvic area.

To participate in this study, you need to be a man between the ages of 18 and 74 with a confirmed diagnosis of localized or locally advanced prostate cancer. You should not have had any previous treatments for prostate cancer and should be in good general health, with a life expectancy of at least 10 years. If you decide to join, you will receive either proton or photon therapy, and researchers will monitor your health to compare the side effects of each treatment. It's important to understand the study requirements and that you'll need to sign a consent form to participate.

Gender

MALE

Eligibility criteria

• 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).