Clinical trial · Interventional
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
- 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)
ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy with photons | Radiation | — | UNRESOLVED |
| Radiotherapy with protons | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Radiotherapy with protons
- description
- Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week
- interventionNames
- Radiation: Radiotherapy with protons
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy with photons
- description
- Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week
- interventionNames
- Radiation: Radiotherapy with photons
- type
- OTHER
- label
- Radiotherapy with photons with lymph drainage vessels
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * life expectancy ≥ 10 years * adenocarcinoma of the prostate confirmed by punch biopsy * locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0 * stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months) * good general condition (ECOG performance status 0 - 1) * marker seed implantation before irradiation (optional) or possibility of Image-guided Radiation Therapy (IGRT) by CT * adequate compliance for follow-up * written informed consent Exclusion Criteria: * distant metastases * previous radiotherapy of the lesser pelvis * previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer * participation in another clinical study, if it's excluded by the study protocols
References
Publications (0)
Data not yet available