Clinical trial NCT05996289: Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)
Official title: Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: radiotherapy
MRI
segmentation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated or being treated for prostatic adenocarcinoma

Brief summary: Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".

Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.

This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :

inter-operator contour variability

* Factors influencing contour
* Impact of contour variability on dosimetry
* Automatic segmentation

Detailed description: Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".

Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.

One of the issues raised by such a study is the methodology used to contour the tumour lesion, an issue which concerns the whole field of radiotherapy. The reference imaging technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion, is multiparametric Magnetic Resonance Imaging. This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :

inter-operator contour variability

* Factors influencing contour
* Impact of contour variability on dosimetry
* Automatic segmentation

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Histologically proven localized prostatic neoplasia on trans-rectal biopsies.
* Multiparametric prostate MRI performed prior to prostate biopsies.
* No opposition expressed
* Patient affiliated to a social security scheme

Exclusion Criteria:

* History of surgery, prostatic irradiation or hormonal treatment prior to diagnosis.
* History of prostate cancer
* No identifiable target lesion on mpMRI (\<PIRADS 3)
* Opposition formulated
* Patient under legal protection (guardianship, curatorship, etc.)

Primary outcomes:
measure: Inter-observer variability
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Clinical factors influencing inter-observer variability.
timeFrame: through study completion, an average of 6 months
measure: Assessing inter-sequence reproducibility
timeFrame: through study completion, an average of 6 months
measure: Dosimetric impact of Inter-observer variability
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: Automatic segmentation of prostatic tumors
timeFrame: through study completion, an average of 6 months
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
affiliation: Radiation Oncology Department, Brest University Hospital
name: Vincent Bourbonne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: