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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiotherapy with protons; Radiation: Radiotherapy with photons

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 Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Hölscher, Dr.; Phone Number: +49 351 458 2238; Email: str.studien@uniklinikum-dresden.de
• Study Contact Backup: Name: Hölscher Tobias, Dr.; Phone Number: +49 351 458 2238; Email: str.studien@uniklinikum-dresden.de

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
    • Contact: Michael Baumann, Prof.; Phone Number: +49 351 458 2238; Email: str.studien@uniklinikum-dresden.de
  • Munich, Germany, 81675
    • Not yet recruiting
    • Klinikum rechts der Isar, Technische Universität München
    • Contact: Stephanie Combs, Prof.
  • Tubingen, Germany, 72076
    • Not yet recruiting
    • Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen
    • Contact: Zips Daniel, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of moderate/ severe side effects	≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects	after 2 years ( measured from the first day of treatment)

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Radiation Oncology Working Group of the German Cancer Society; German Consortium for Translational Cancer Research; National Center for Radiation Research in Oncology Dresden/Heidelberg
• Investigators: Study Chair: Tobias Hölscher, Dr., University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): February 1, 2026

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; proton radiotherapy; photon radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STR - ProtoChoice-P - 2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No