MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging

NCT03293602 | Withdrawn

• 1 other identifier: CHUBX 2014/26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; MRI; BOLD; 18F-MISO; PET

Outcome Measures

Primary Outcomes (1)

• comparison between histological results and oxygenation quantitative values from MRI and PET exams

  Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and: * on one hand PET FMISO uptake * on the other hand, MRI BOLD signal

  Inclusion, 1 month

Secondary Outcomes (1)

• quantitative analysis

  Inclusion, 1 month

Study Arms (1)

F-MISO PET imaging

EXPERIMENTAL

F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.

Device: F-MISO PET imaging

Interventions

F-MISO PET imaging DEVICE

F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.

F-MISO PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Cancéropôle GSO and GIRCI SOOM (API-K): collaborator

Study Sites (1)

Centre de Lutte Contre le Cancer

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: September 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)