PET/MR for Prostate Cancer Restaging: a Phase II Prospective Monocentric Study

NCT ID: NCT05806853

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2022-10-05

Brief Summary

The overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2)

Detailed Description

Sixty consecutive patients with biochemical recurrence (PSA≥0.2 ng/ml), previously treated with radical prostatectomy for organ confined prostate cancer will be enrolled; patients with previous and/or concomitant androgen deprivation therapy will be excluded from enrolment.

All patients will undergo both 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging at San Raffaele Scientific Institute in two different days; all clinical and pathological variables available at the time of PET/MR studies will be recorded for each patient.

PET/MR results will be compared to other imaging procedures performed and available in the course of routinely work-up evaluation. Treatment approach will be based on all available clinical and instrumental data, including 68Ga-PSMA and 68Ga-RM2 PET/MR, evaluated during multidisciplinary sessions including expert Urologists, Nuclear Medicine and Radiologist physicians. Patients with local recurrence will be candidate to salvage radiation therapy (sRT). Patients presenting only LN recurrence will be proposed to be submitted to salvage lymph node (LN) dissection (sLND) or sRT; alternatively, conventional androgen deprivation therapy will be performed in those patients who will not be willing to undergo secondary surgery or radiation therapy.

To assess the diagnostic accuracy of 68Ga-PSMA and 68Ga-RM2 PET/MR, images will be validated with: 1) histology (when deemed necessary by the clinician as expected under the normal care pathway) obtained by echographically-guided biopsy in suspected local recurrence or during sLND in the event of suspected nodal recurrence; 2) biochemical response after tailored treatment in patients submitted to sRT for local or LN recurrence 3) conventional imaging modalities performed to assess disease status as part of the routine clinical work-up. 68Ga-PSMA and 68Ga-RM2 PET/MR will be correlated with available clinical and pathological features. To assess the impact of 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR in changing patients' management, patients will be followed-up after the execution of PET/MR studies. Patients will be followed-up until the end of the study period

Conditions

Prostate Cancer

Study Design

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

Study Groups

Dual tracer PET/MRI

All patients undergo PET/MRI with 68Ga-PSMA and 68Ga-DOTA-RM2. 68Ga-PSMA dose: 160 +-50 MBq, route of administration: intravenous 68Ga-DOTA-RM2 dose: 140 +-50 MBq, route of administration: intravenous

Group Type: EXPERIMENTAL

68Ga-PSMA

Intervention Type: DRUG

Glu-NH-CO-NH-Lys-(Ahx)-\[68Ga(HBED-CC)\] (68Ga-PSMA)

68Ga-RM2

Intervention Type: DRUG

Bombesin receptor antagonist (68Ga-RM2)

Interventions

68Ga-PSMA

Glu-NH-CO-NH-Lys-(Ahx)-\[68Ga(HBED-CC)\] (68Ga-PSMA)

Intervention Type: DRUG

68Ga-RM2

Bombesin receptor antagonist (68Ga-RM2)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with histological proven diagnosis of prostate cancer.
• Patients treated with radical therapy (RP o EBRT, with or without further adjuvant therapies), who present rising serum PSA values ≥ 0.2 ng/mL.
• Age ≥ 18 years-old.
• Willing to provide a signed informed consent.

Exclusion Criteria

• Age < 18 years-old.
• Previous and/or concomitant androgen deprivation therapy will be excluded.
• Any additional medical condition that may significantly interfere with study compliance.
• Contraindications to MR study (i.e. Pacemaker

• 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

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PCa Restaging- PET/MR

Identifier Type: -

Identifier Source: org_study_id