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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radiotherapy with protons
Radiotherapy with photons
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, proton radiotherapy, photon radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation OncologyRecruiting
  • Klinikum rechts der Isar, Technische Universität München
  • Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Radiotherapy with protons

Radiotherapy with photons

Radiotherapy with photons with lymph drainage vessels

Arm Description

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

Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week

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

Outcomes

Primary Outcome Measures

Cumulative incidence of moderate/ severe side effects
≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects

Secondary Outcome Measures

Full Information

First Posted
May 9, 2016
Last Updated
February 6, 2023
Sponsor
Technische Universität Dresden
Collaborators
German Consortium for Translational Cancer Research, National Center for Radiation Research in Oncology Dresden/Heidelberg, Radiation Oncology Working Group of the German Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT02766686
Brief Title
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons
Acronym
ProtoChoice-P
Official Title
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
German Consortium for Translational Cancer Research, National Center for Radiation Research in Oncology Dresden/Heidelberg, Radiation Oncology Working Group of the German Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, proton radiotherapy, photon radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy with protons
Arm Type
Experimental
Arm Description
Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week
Arm Title
Radiotherapy with photons
Arm Type
Active Comparator
Arm Description
Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week
Arm Title
Radiotherapy with photons with lymph drainage vessels
Arm Type
Other
Arm Description
Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with protons
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with photons
Primary Outcome Measure Information:
Title
Cumulative incidence of moderate/ severe side effects
Description
≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects
Time Frame
after 2 years ( measured from the first day of treatment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Hölscher, Dr.
Phone
+49 351 458 2238
Email
str.studien@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hölscher Tobias, Dr.
Phone
+49 351 458 2238
Email
str.studien@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Hölscher, Dr.
Organizational Affiliation
University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Baumann, Prof.
Phone
+49 351 458 2238
Email
str.studien@uniklinikum-dresden.de
Facility Name
Klinikum rechts der Isar, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Combs, Prof.
Facility Name
Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zips Daniel, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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