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

Overview

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.

Full Title of Study: “Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Radiotherapy with protons
    • Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week
  • 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
  • Other: Radiotherapy with photons with lymph drainage vessels
    • Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität Dresden
  • Collaborator
    • German Consortium for Translational Cancer Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tobias Hölscher, Dr. Tobias Hölscher – Technische Universität Dresden
  • Overall Official(s)
    • Tobias Hölscher, Dr., Study Chair, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
  • Overall Contact(s)
    • Tobias Hölscher, Dr., +49 351 458 2238, str.studien@uniklinikum-dresden.de

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