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

Last updated: February 6, 2023
Sponsor: Technische Universität Dresden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT02766686
STR - ProtoChoice-P - 2015
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • life expectancy ≥ 10 years
  • adenocarcinoma of the prostate confirmed by punch biopsy
  • locally limited to locally advanced adenocarcinomas without evidence of distantmetastases 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-guidedRadiation Therapy (IGRT) by CT
  • adequate compliance for follow-up
  • written informed consent

Exclusion

Exclusion Criteria:

  • distant metastases
  • previous radiotherapy of the lesser pelvis
  • previous or concomitant other malignant disease except when there is no impact ontreatment or follow-up of the prostate cancer
  • participation in another clinical study, if it's excluded by the study protocols

Study Design

Total Participants: 146
Study Start date:
September 01, 2016
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology

    Dresden, 01307
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar, Technische Universität München

    Munich, 81675
    Germany

    Site Not Available

  • Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen

    Tubingen, 72076
    Germany

    Site Not Available

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