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PET/MRI to Stage Prostate Cancer Patients

RECRUITINGPhase 2Sponsored by IRCCS San Raffaele
Actively Recruiting
PhasePhase 2
SponsorIRCCS San Raffaele
Started2020-09-09
Est. completion2025-09-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06484361

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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