Comparing proton and photon radiotherapy for prostate cancer
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
This study is testing whether proton therapy can cause fewer side effects than traditional photon therapy for men with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | Radiation |
| Locations | 3 sites (Dresden and 2 other locations) |
| Trial ID | NCT02766686 on ClinicalTrials.gov |
What this trial studies
ProtoChoice-P is a multicenter trial designed to evaluate the effectiveness of proton therapy in treating prostate cancer. The primary goal is to reduce moderate to severe genito-urinary and intestinal side effects associated with radiation therapy. The study will compare outcomes between patients receiving proton therapy and those receiving traditional photon therapy, focusing on quality of life, biochemical recurrence, and overall survival. Patients will be matched based on various criteria to ensure a fair comparison, as randomization is not feasible due to limited proton facilities.
Who should consider this trial
Good fit: Ideal candidates include men with locally advanced adenocarcinoma of the prostate who have a life expectancy of at least 10 years and meet specific health criteria.
Not a fit: Patients with distant metastases or those who have previously undergone pelvic radiotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce side effects for prostate cancer patients undergoing radiotherapy.
How similar studies have performed: Previous studies have shown promising results with proton therapy, suggesting potential benefits over traditional photon therapy, although this specific comparative approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dresden and 2 other locations
- University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology — Dresden, Germany (Recruiting)
- Klinikum rechts der Isar, Technische Universität München — Munich, Germany (Not_yet_recruiting)
- Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen — Tubingen, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Tobias Hölscher, Dr.
- Email: str.studien@uniklinikum-dresden.de
- Phone: +49 351 458 2238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.