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Trial record 1 of 1 for:    protochoice-p Dresden
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Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons (ProtoChoice-P)

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ClinicalTrials.gov Identifier: NCT02766686
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : February 8, 2023
Sponsor:
Collaborators:
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Radiation Oncology Working Group of the German Cancer Society
Information provided by (Responsible Party):
Tobias Hölscher, Technische Universität Dresden

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiotherapy with protons Radiation: Radiotherapy with photons Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
Study Start Date : September 2016
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiotherapy with protons
Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week
 Radiation: Radiotherapy with protons
Active Comparator: Radiotherapy with photons
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
Radiotherapy with photons with lymph drainage vessels
Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week
 Radiation: Radiotherapy with photons


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766686


Contacts
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Contact: Tobias Hölscher, Dr. +49 351 458 2238 str.studien@uniklinikum-dresden.de
Contact: Hölscher Tobias, Dr. +49 351 458 2238 str.studien@uniklinikum-dresden.de

Locations
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Germany
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology Recruiting
Dresden, Germany, 01307
Contact: Michael Baumann, Prof.    +49 351 458 2238    str.studien@uniklinikum-dresden.de   
Klinikum rechts der Isar, Technische Universität München Not yet recruiting
Munich, Germany, 81675
Contact: Stephanie Combs, Prof.         
Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen Not yet recruiting
Tubingen, Germany, 72076
Contact: Zips Daniel, Prof.         
Sponsors and Collaborators
Technische Universität Dresden
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Radiation Oncology Working Group of the German Cancer Society
Investigators
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Study Chair: Tobias Hölscher, Dr. University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
More Information
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Responsible Party: Tobias Hölscher, Dr. Tobias Hölscher, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02766686    
Other Study ID Numbers: STR - ProtoChoice-P - 2015
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tobias Hölscher, Technische Universität Dresden:
Prostate cancer
proton radiotherapy
photon radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases