Palo Alto, California 94304

  • Prostate Adenocarcinoma

Purpose:

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


Study summary:

PRIMARY OBJECTIVES: I. To evaluate 68Ga-RM2 (formerly known as DOTA bombesin or BAY 86-7548) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA) and non-contributory computed tomography (CT). OUTLINE: Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. After completion of study, patients are followed up at 24-48 hours and then at 1 year.


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


NCT ID:

NCT02624518


Primary Contact:

Principal Investigator
Andrei Iagaru
Stanford University

Risa Jiron
Phone: 650-736-1598
Email: rjiron@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Risa Jiron
Phone: 650-736-1598
Email: rjiron@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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