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Ion Prostate Irradiation (IPI)

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ClinicalTrials.gov Identifier: NCT01641185
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: radiation Phase 2

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


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

  2. OS [ Time Frame: 3 years ]
  3. quality of life [ Time Frame: 3 years ]
    by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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


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