Ion Prostate Irradiation (IPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01641185
First received: July 6, 2012
Last updated: December 5, 2015
Last verified: May 2014
  Purpose
The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of the prostate with carbon ions or protons using the raster scan technique.

Condition Intervention Phase
Prostatic Neoplasms
Procedure: radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • proctitis and cystitis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    via incidence grade 3-4 toxicity (NCI-CTC-AE)


Secondary Outcome Measures:
  • PSA-PFS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    by measuring PSA values every 3 months

  • OS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    by questionnaire


Enrollment: 92
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protons
irradiation 20 x 3,3 GyE protons
Procedure: radiation
radiation with protons or carbon ions
Experimental: carbon ions
irradiation 20 x 3,3 GyE carbon ions
Procedure: radiation
radiation with protons or carbon ions

Detailed Description:

as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

http://www.ncbi.nlm.nih.gov/pubmed/24641841

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of <15% calculated by the Yale-formula; Risk [%] = [GS -5] x [PSA/3 + 1.5 x T], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

  • Karnofsky-Index ≥ 70%
  • age between 40 and 80 years
  • PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641185

Locations
Germany
University of Heidelberg, Radiooncology, HIT
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Klaus Herfarth, Prof. Dr. University Hospital of Heidelberg
  More Information

Publications:
Responsible Party: Klaus Herfarth, MD, Prof. Dr. Herfarth, Heidelberg University
ClinicalTrials.gov Identifier: NCT01641185     History of Changes
Other Study ID Numbers: IPI 
Study First Received: July 6, 2012
Last Updated: December 5, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
prostate
IPI
hypofractionation
carbon ions
proton

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 07, 2016