PET/MRI to Stage Prostate Cancer Patients

Trial Title: PET/MRI to Stage Prostate Cancer Patients

NCT ID: NCT06484361

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Gallium 68 PSMA-11

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-PSMA
Description: all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
Arm group label: Arm 1

Intervention type: Drug
Intervention name: 68Ga-RM2
Description: all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
Arm group label: Arm 1

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

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IRCCS Ospedale San Raffaele

Address:
City: Milan
Zip: 20132
Country: Italy

Status: Recruiting

Contact:
Last name: Maria Picchio, MD

Phone: +39 02 26436117
Email: picchio.maria@hsr.it

Start date: September 9, 2020

Completion date: September 30, 2025

Lead sponsor:
Agency: IRCCS San Raffaele
Agency class: Other

Source: IRCCS San Raffaele

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06484361