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Completed

NCT Number: NCT01641185

Ion Prostate Irradiation

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Heidelberg, Radiooncology, HIT

Heidelberg, 69120, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation

Procedure

radiation with protons or carbon ions

Primary outcomes

  1. proctitis and cystitis

    Time frame: 3 years

    via incidence grade 3-4 toxicity (NCI-CTC-AE)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate

Acronym: IPI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2012
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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