Clinical trial NCT03293602: MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging
Official title: MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
MRI
BOLD
18F-MISO
PET
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Cancéropôle GSO and GIRCI SOOM (API-K)
First posted: 2017-09-26
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

Detailed description: Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol \&al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic \& al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers

Eligibility criteria: Inclusion Criteria:

* Patient above 18.
* Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
* High risk patient : \>T2c grade, Glasgow score \> 7 and PSA \> 20ng/ml
* Surgical treatment chosen during multidisciplinary meeting
* ECOG ≤2
* Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
* Member or beneficiary of a social security system.
* Signed informed consent.

Exclusion Criteria:

* Patient included in another clinical study
* Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring
* Patient deprive of liberty, adult subjects to legal protection or unable to give consent
* Contraindications to MRI
* Contraindication to gadolinium injection

Primary outcomes:
measure: comparison between histological results and oxygenation quantitative values from MRI and PET exams
timeFrame: Inclusion, 1 month
Secondary outcomes:
measure: quantitative analysis
timeFrame: Inclusion, 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre de Lutte Contre le Cancer
Study officials:
References: