Clinical trial · Interventional
Protons vs. Photons for High-risk Prostate Cancer
Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons
NCT05350475CI-TRIAL-00121929active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon therapy | Radiation | — | UNRESOLVED |
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proton therapy
- description
- Radiation: Proton Therapy 78 Gray (Gy) in 39 fractions with 56 Gy to the Pelvic Lymph Nodes (LN), 5 days a week. Androgen Deprivation Therapy (ADT) for three years, starting 3 months before Proton Therapy.
- interventionNames
- Radiation: Proton therapy
- type
- ACTIVE_COMPARATOR
- label
- Photon Therapy
- description
- Radiation: Photon Therapy 78 Gy in 39 fractions with 56 Gy to the pelvic LN, 5 days a week. ADT for three years, starting 3 months before Photon Therapy.
- interventionNames
- Radiation: Photon therapy
Primary outcomes (1)
- measure
- Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.