NCT01898065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

2.4 years

First QC Date

July 3, 2013

Last Update Submit

November 6, 2015

Conditions

Prostate Adenocarcinoma

Keywords

HypoxiaradiotherapyPET with 18-F-MISOMRI

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 to 4 weeks after beginning of radiation therapy

Secondary Outcomes (1)

  • To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.

    before and 3 to 4 weeks after the begining of radiation therapy

Study Arms (1)

PET imaging, 18 F-miso

EXPERIMENTAL

Single Arm study

Drug: 18-F-MISO

Interventions

18-F-MISODRUG

PET scan with the 18 Fluoro Misonidazole

Also known as: 18 Fluoro Misonidazole
PET imaging, 18 F-miso

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old
  • Patient protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Poitiers

Poitiers, 86000, France

Location

ICO Rene Gauducheau

Saint-Herblain, 44805, France

Location

Related Publications (2)

  • 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.

    PMID: 8892467RESULT

  • 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.

    PMID: 15683820RESULT

Related Links

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • SUPIOT Stéphane, MD

    ICO René Gauducheau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 12, 2013

Study Start

June 1, 2012

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

FR(2)