NCT06484361

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2020

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

5.1 years

First QC Date

March 22, 2023

Last Update Submit

June 25, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer

    All patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 and then imaging findings will be correlated to histopathological findings gathered after prostatectomy. Specifically, at the patient level, we will count the number of patients where the different imaging modalities identified at least one intraprostatic cancer lesion. At the lesion level, on the other hand, we will match the intraprostatic lesions identified at imaging with those detected at histopathological examination. Therefore, providing measures of sensitivity, specificity, PPV, NPV for each imaging modality investigated ( 68Ga-PSMA PET, 68Ga-RM2 PET and MRI) at the lesion level.

    baseline

Secondary Outcomes (5)

  • To optimize PET/MRI with 68Ga-PSMA and 68Ga-RM2 protocol by using novel imaging technique to stage PCa patients.

    baseline

  • To characterize the primary PCa phenotype in high-grade patients

    baseline

  • To evaluate the stability and reproducibility of imaging features in mp-MRI with test-retest procedure.

    baseline

  • To evaluate the diagnostic accuracy of PET/MRI with 68Ga-PSMA and 68Ga-RM2 to stage T, N and M parameters in PCa patients.

    24 months after baseline

  • To evaluate patient management based on PET/MRI studies.

    24 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Dual tracer PET/MRI

Drug: 68Ga-PSMADrug: 68Ga-RM2

Interventions

68Ga-PSMADRUG

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

Arm 1
68Ga-RM2DRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years-old
  • Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy.
  • Willing to provide a signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11BAY 86-7548

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Maria Picchio, MD

CONTACT

+39 02 26436117picchio.maria@hsr.it

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

July 3, 2024

Study Start

September 9, 2020

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)