Clinical trial

Phase II Prospective Monocentric Study on Prostate Cancer Restaging by Using PET/MR With Innovative Radiotracers

Name

PCa Restaging- PET/MR

Description

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)

Trial arms

Trial start

2020-06-03

Estimated PCD

2022-10-05

Trial end

2022-10-05

Status

Completed

Phase

Early phase I

Treatment

68Ga-PSMA

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

Arms:

Dual tracer PET/MRI

68Ga-RM2

Bombesin receptor antagonist (68Ga-RM2)

Arms:

Dual tracer PET/MRI

Size

Primary endpoint

To evaluate the diagnostic accuracy of 68Ga-PSMA PET/MR to identify the site of recurrence in patients with biochemical relapse of PCa after primary treatment and comparison with the performances of 68Ga-RM2 PET/MR

Imaging will be performed at T0 and T1 (at least 2 days apart). PET/MR results will be compared to other imaging procedures performed in the course of routinely work-up evaluation.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-04-10

1 organization

1 product

1 drug

1 indication

Organization

Drug

Indication

Product