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Ion Prostate Irradiation (IPI)

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

radiation

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate, IPI, hypofractionation, carbon ions, proton

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of Heidelberg, Radiooncology, HIT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

protons

carbon ions

Arm Description

irradiation 20 x 3,3 GyE protons

irradiation 20 x 3,3 GyE carbon ions

Outcomes

Primary Outcome Measures

proctitis and cystitis

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

Secondary Outcome Measures

PSA-PFS

by measuring PSA values every 3 months

quality of life

by questionnaire

Full Information

NCT ID

NCT01641185

First Posted

July 6, 2012

Last Updated

May 1, 2017

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT01641185

Brief Title

Ion Prostate Irradiation

Acronym

IPI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

prostate, IPI, hypofractionation, carbon ions, proton

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

protons

Arm Type

Experimental

Arm Description

irradiation 20 x 3,3 GyE protons

Arm Title

carbon ions

Arm Type

Experimental

Arm Description

irradiation 20 x 3,3 GyE carbon ions

Intervention Type

Procedure

Intervention Name(s)

radiation

Intervention Description

radiation with protons or carbon ions

Primary Outcome Measure Information:

Title

proctitis and cystitis

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

PSA-PFS

Description

by measuring PSA values every 3 months

Time Frame

3 years

Title

Time Frame

3 years

Title

quality of life

Description

by questionnaire

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Herfarth, Prof. Dr.

Organizational Affiliation

University Hospital of Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Heidelberg, Radiooncology, HIT

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24641841

Citation

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 Mar 19;14:202. doi: 10.1186/1471-2407-14-202.

Results Reference

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PubMed Identifier

27084659

Citation

Habl G, Uhl M, Katayama S, Kessel KA, Hatiboglu G, Hadaschik B, Edler L, Tichy D, Ellerbrock M, Haberer T, Wolf MB, Schlemmer HP, Debus J, Herfarth K. Acute Toxicity and Quality of Life in Patients With Prostate Cancer Treated With Protons or Carbon Ions in a Prospective Randomized Phase II Study--The IPI Trial. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):435-443. doi: 10.1016/j.ijrobp.2016.02.025. Epub 2016 Feb 12.

Results Reference

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Ion Prostate Irradiation

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