Ion Prostate Irradiation (IPI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth - Dr. J. Debus, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01641185
First received: July 6, 2012
Last updated: May 25, 2014
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
Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons
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


Estimated Enrollment: 92
Study Start Date: May 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protons
20 x 3,3 GyE protons
Procedure: radiation
radiation with protons or carbon ions
Experimental: carbon ions
20 x 3,3 GyE carbon ions
Procedure: radiation
radiation with protons or carbon ions

  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
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klaus Herfarth - Dr. J. Debus, 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: May 25, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on October 16, 2014