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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Radiotherapy with protons
* Radiation: Radiotherapy with photons


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy with protons<br>Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week | Radiation: Radiotherapy with protons<br> <br> |
| Active Comparator: Radiotherapy with photons<br>Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week | Radiation: Radiotherapy with photons<br> <br> |
| Other: Radiotherapy with photons with lymph drainage vessels<br>Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week | Radiation: Radiotherapy with photons<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of moderate/ severe side effects | ≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects | after 2 years ( measured from the first day of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, proton radiotherapy, photon radiotherapy