PET/MRI to Stage Prostate Cancer Patients

NCT ID: NCT06484361

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2025-09-30

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1

Dual tracer PET/MRI

Group Type: EXPERIMENTAL

68Ga-PSMA

Intervention Type: DRUG

all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention

68Ga-RM2

Intervention Type: DRUG

all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention

Interventions

68Ga-PSMA

all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention

Intervention Type: DRUG

68Ga-RM2

all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Maria Picchio

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Picchio, MD

Role: CONTACT

picchio.maria@hsr.it

+39 02 26436117

Facility Contacts

Maria Picchio, MD

Role: primary

picchio.maria@hsr.it

+39 02 26436117

Other Identifiers

PETMR-Staging-PCa1

Identifier Type: -

Identifier Source: org_study_id