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

Prostate Adenocarcinoma Clinical Trial

— HYPOXProstat  

Official title:

Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898065
• Other study ID #: RC11-080
• Secondary ID: 2011-004582-32
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: November 6, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Drug:
• 18-F-MISO
PET scan with the 18 Fluoro Misonidazole

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers
France	ICO Rene Gauducheau	St Herblain

Sponsors (4)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	Cyclopharma, IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA, Poitiers University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

Bentzen SM. Theragnostic imaging for radiation oncology: dose-painting by numbers. Lancet Oncol. 2005 Feb;6(2):112-7. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	before and 3 to 4 weeks after the begining of radiation therapy	No