Clinical trial NCT06484361: PET/MRI to Stage Prostate Cancer Patients
Official title: Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PET/MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
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: The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist).

50 patients with biopsy proven PCa will be studied by PET/MRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy.

Detailed description: This is a prospective monocentric open study (Phase II study). The study will include 50 consecutive PCa patients who will be recruited in the first 36 months of the study. All clinical and pathological variables available at the time of PET/MRI will be recorded for each patient and all patients will take a blood sample before the first PET/MRI study. All patients will undergo 68Ga-PSMA and 68Ga-RM2 PET/MRI studies at San Raffaele Hospital in two different days (\> 48 hours between the two studies) and within one month from each other.

Then, patients will undergo surgical intervention (prostatectomy and pelvic/retroperitoneal lymphadenectomy) and the surgically removed prostate will be fixated and processed. Ex-vivo 3T-MRI study will be performed on the processed specimen (prostate gland) and afterwards, the prostate will be examined by a dedicated pathologist. Spatial coregistration of in vivo, ex-vivo and histopathological images will be performed so that the annotation (dominant tumor lesion) made by the pathologist will be translated onto in vivo PET/MR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years-old
* Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy.
* Willing to provide a signed informed consent

Exclusion Criteria:

* Age \< 18 years-old
* Inability to complete the needed imaging examinations (i.e. severe claustrophobia)
* Any additional medical condition that may significantly interfere with study compliance
* All the contraindications for MRI study (i.e. pacemaker)
* Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure

Primary outcomes:
measure: To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer
timeFrame: baseline
Secondary outcomes:
measure: To optimize PET/MRI with 68Ga-PSMA and 68Ga-RM2 protocol by using novel imaging technique to stage PCa patients.
timeFrame: baseline
measure: To characterize the primary PCa phenotype in high-grade patients
timeFrame: baseline
measure: To evaluate the stability and reproducibility of imaging features in mp-MRI with test-retest procedure.
timeFrame: baseline
measure: To evaluate the diagnostic accuracy of PET/MRI with 68Ga-PSMA and 68Ga-RM2 to stage T, N and M parameters in PCa patients.
timeFrame: 24 months after baseline
measure: To evaluate patient management based on PET/MRI studies.
timeFrame: 24 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: