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Ion Prostate Irradiation (IPI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641185
First Posted: July 16, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Klaus Herfarth, MD, Heidelberg University:

Primary Outcome Measures:
  • proctitis and cystitis [ Time Frame: 3 years ]
    via incidence grade 3-4 toxicity (NCI-CTC-AE)


Secondary Outcome Measures:
  • PSA-PFS [ Time Frame: 3 years ]
    by measuring PSA values every 3 months

  • OS [ Time Frame: 3 years ]
  • quality of life [ Time Frame: 3 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 6, 2012
First Posted: July 16, 2012
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Klaus Herfarth, MD, Heidelberg University:
prostate
IPI
hypofractionation
carbon ions
proton

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