Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons

Summary

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.

Eligibility

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

Conditions2

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