NCT05350475 Protons Vs. Photons for High-risk Prostate Cancer
| NCT ID | NCT05350475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2022-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Stine Elleberg Petersen, MD, Ph.D
PRINCIPAL INVESTIGATOR
Danish Centre for Particle Therapy, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT05350475 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05350475 currently recruiting?
Yes, NCT05350475 is actively recruiting participants. Contact the research team at stinpete@rm.dk for enrollment information.
Where is the NCT05350475 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark, Aarhus, Denmark, Aalborg, Denmark and 3 additional locations.
Who is sponsoring the NCT05350475 clinical trial?
NCT05350475 is sponsored by University of Aarhus. The principal investigator is Stine Elleberg Petersen, MD, Ph.D at Danish Centre for Particle Therapy, Aarhus University Hospital. The trial plans to enroll 400 participants.
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