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

NCT05806853 | Completed Phase 2

• 1 other identifier: PCa Restaging- PET/MR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostate Cancer

Keywords

prostate cancer; biochemical recurrence; PET/MR

Outcome Measures

Primary Outcomes (1)

• 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

  Diagnostic accuracy will be measured by sensitivity, specificity, positive predicted value and negative predicted value

  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.

Secondary Outcomes (2)

• To correlate 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging with clinical and pathological features.

  Imaging will be performed at T0 and T1 (at least 2 days apart). Analysis after enrollment completion

• To evaluate the results of a lesion-targeted approach in terms of biochemical-recurrence-free survival and clinical recurrence-free survival

  0-36 months

Study Arms (1)

Dual tracer PET/MRI

EXPERIMENTAL

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

Drug: 68Ga-PSMA; Drug: 68Ga-RM2

Interventions

68Ga-PSMA DRUG

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

Dual tracer PET/MRI

68Ga-RM2 DRUG

Bombesin receptor antagonist (68Ga-RM2)

Dual tracer PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; BAY 86-7548

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 10, 2023
• Study Start: June 3, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)