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Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer (HYPOXProstat)

Primary Purpose

Prostate Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
18-F-MISO
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma focused on measuring Hypoxia, radiotherapy, PET with 18-F-MISO, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically proven prostate adenocarcinoma
  • Absence of metastases (lymph node or bone)
  • One or more tumor nodules seen on MRI and PET Choline.
  • Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)<20 ng / ml, T <T2c or Gleason 6 and PSA 10-20 ng / ml, T <T2c
  • No concomitant hormonal treatment. (NB: the introduction of hormone therapy during radiotherapy before the second 18F-MISO is a criterion to study exit)
  • Indication of radiotherapy up to a total dose> 70 Gy and 2 Gy/day fractions
  • Signed Informed consent
  • Social Insurance

Exclusion Criteria:

  • Age < 18 years old
  • Patient protected by law

Sites / Locations

  • CHU Poitiers
  • ICO Rene Gauducheau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET imaging, 18 F-miso

Arm Description

Single Arm study

Outcomes

Primary Outcome Measures

To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
First PET-scan with 18-F-Miso done before radiation Second PET-scan with 18-F-Miso done 3 to 4 weeks after the beginning of radiation therapy.

Secondary Outcome Measures

To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.
Images obtained with PET Choline and MRI (anatomical location) will be merge with images obtained by 18F-MISO PET to search hypoxia on these anatomical areas.

Full Information

First Posted
July 3, 2013
Last Updated
November 6, 2015
Sponsor
Institut Cancerologie de l'Ouest
Collaborators
Poitiers University Hospital, IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA, Cyclopharma
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1. Study Identification

Unique Protocol Identification Number
NCT01898065
Brief Title
Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer
Acronym
HYPOXProstat
Official Title
Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
Collaborators
Poitiers University Hospital, IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA, Cyclopharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation. In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy. If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed. If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered. This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Hypoxia, radiotherapy, PET with 18-F-MISO, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET imaging, 18 F-miso
Arm Type
Experimental
Arm Description
Single Arm study
Intervention Type
Drug
Intervention Name(s)
18-F-MISO
Other Intervention Name(s)
18 Fluoro Misonidazole
Intervention Description
PET scan with the 18 Fluoro Misonidazole
Primary Outcome Measure Information:
Title
To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
Description
First PET-scan with 18-F-Miso done before radiation Second PET-scan with 18-F-Miso done 3 to 4 weeks after the beginning of radiation therapy.
Time Frame
3 to 4 weeks after beginning of radiation therapy
Secondary Outcome Measure Information:
Title
To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.
Description
Images obtained with PET Choline and MRI (anatomical location) will be merge with images obtained by 18F-MISO PET to search hypoxia on these anatomical areas.
Time Frame
before and 3 to 4 weeks after the begining of radiation therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically proven prostate adenocarcinoma Absence of metastases (lymph node or bone) One or more tumor nodules seen on MRI and PET Choline. Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)<20 ng / ml, T <T2c or Gleason 6 and PSA 10-20 ng / ml, T <T2c No concomitant hormonal treatment. (NB: the introduction of hormone therapy during radiotherapy before the second 18F-MISO is a criterion to study exit) Indication of radiotherapy up to a total dose> 70 Gy and 2 Gy/day fractions Signed Informed consent Social Insurance Exclusion Criteria: Age < 18 years old Patient protected by law
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUPIOT Stéphane, MD
Organizational Affiliation
ICO René Gauducheau
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
ICO Rene Gauducheau
City
St Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
8892467
Citation
Rasey JS, Koh WJ, Evans ML, Peterson LM, Lewellen TK, Graham MM, Krohn KA. Quantifying regional hypoxia in human tumors with positron emission tomography of [18F]fluoromisonidazole: a pretherapy study of 37 patients. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):417-28. doi: 10.1016/s0360-3016(96)00325-2.
Results Reference
result
PubMed Identifier
15683820
Citation
Bentzen SM. Theragnostic imaging for radiation oncology: dose-painting by numbers. Lancet Oncol. 2005 Feb;6(2):112-7. doi: 10.1016/S1470-2045(05)01737-7.
Results Reference
result

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Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer

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