Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons (ProtoChoice-P)

  • STATUS
    Recruiting
  • End date
    Aug 26, 2023
  • participants needed
    146
  • sponsor
    Technische Universität Dresden
Updated on 24 February 2022
androgens
androgen suppression
adenocarcinoma
adenocarcinoma of prostate
immunological adjuvant

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.

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.

Details
Condition Prostate Cancer
Treatment Radiotherapy with protons, Radiotherapy with photons
Clinical Study IdentifierNCT02766686
SponsorTechnische Universität Dresden
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
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