NCT02766686

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

7.4 years

First QC Date

May 9, 2016

Last Update Submit

February 6, 2023

Conditions

Prostate Cancer

Keywords

Prostate cancerproton radiotherapyphoton radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

Radiotherapy with protons

EXPERIMENTAL

Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week

Radiation: Radiotherapy with protons

Radiotherapy with photons

ACTIVE COMPARATOR

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

OTHER

Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week

Radiation: Radiotherapy with photons

Interventions

Radiotherapy with protonsRADIATION
Radiotherapy with protons
Radiotherapy with photonsRADIATION
Radiotherapy with photonsRadiotherapy with photons with lymph drainage vessels

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Dresden, 01307, Germany

RECRUITING

Klinikum rechts der Isar, Technische Universität München

Munich, 81675, Germany

NOT YET RECRUITING

Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen

Tübingen, 72076, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

RadiotherapyProtonsPhotons

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical PhenomenaLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Tobias Hölscher, Dr.

    University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

    STUDY CHAIR

Central Study Contacts

Tobias Hölscher, Dr.

CONTACT

+49 351 458 2238str.studien@uniklinikum-dresden.de

Hölscher Tobias, Dr.

CONTACT

+49 351 458 2238str.studien@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Tobias Hölscher

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 10, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)