Houston, Texas 77030


Purpose:

This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.


Study summary:

PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response. SECONDARY OBJECTIVES: I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement. II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 [PCWG2] criteria). III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response. OUTLINE: Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (IV) then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.


Criteria:

Inclusion Criteria: - Histologically or cytologically proven prostate carcinoma - Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI) - Castration naive disease, no prior systemic therapy for prostate cancer - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Ability to understand and willingness to sign informed consent Exclusion Criteria: - Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely - Known brain metastasis - Small cell carcinoma of the prostate


NCT ID:

NCT04134208


Primary Contact:

Principal Investigator
Gregory C Ravizzini
M.D. Anderson Cancer Center

Gregory Ravizzini
Phone: 713-745-5721
Email: gravizzini@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Gregory C. Ravizzini
Phone: 713-745-5721

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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