Clinical trial NCT02766686: Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons
Official title: Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
proton radiotherapy
photon radiotherapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Consortium for Translational Cancer Research
name: National Center for Radiation Research in Oncology Dresden/Heidelberg
name: Radiation Oncology Working Group of the German Cancer Society
First posted: 2016-05-10
Enrollment: 146
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.

Eligibility 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

Primary outcomes:
measure: Cumulative incidence of moderate/ severe side effects
timeFrame: after 2 years ( measured from the first day of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Tubingen
country: Germany
facility: Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen
Study officials:
affiliation: University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
name: Tobias Hölscher, Dr.
role: STUDY_CHAIR
References: