Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00011166

Trial Description

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Title

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

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Trial Acronym

ProtoChoice-P

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00011166
  •   2016/10/17
  •   2016/05/09
  •   yes
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Secondary IDs

  •   NCT02766686  (ClinicalTrials.gov)
  •   STR - ProtoChoice-P - 2015  (Technische Universität Dresden)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Radiation: Radiotherapy with protons
  •   Radiation: Radiotherapy with photons
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Other
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Cumulative incidence of moderate/ severe side effects; time frame: after 2 years ( measured from the first day of treatment); ≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2016/09/30
  •   146
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Technische Universität Dresden
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    • German Consortium for Translational Cancer Research (DKTK)
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    • National Center for Radiation Research in Oncology Dresden/Heidelberg
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    • Radiation Oncology Working Group of the German Cancer Society
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    • University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
    • Baumann Michael, Dr. 
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    • Michael Baumann, Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/10/05


* This entry means the parameter is not applicable or has not been set.