68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic resonance imaging (MRI) works in detecting prostate cancer in patients with negative computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and combine them into a single picture and is used to describe information regarding the function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a radioactive agent linked to a pharmacological substance that is strongly attracted by a substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Treatments: Bombesin

Criteria

Inclusion Criteria:

• Biopsy proven prostate adenocarcinoma

• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy

• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured 6-13 weeks after RP

• Confirmatory persistent PSA greater than 0.2 ng/mL

• Post-radiation therapy - American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition

• Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA

• No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and negative contrast-enhanced CT

• Able to provide written consent

• Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

• Unable to provide informed consent

• Inability to lie still for the entire imaging time

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance

• Metallic implants