Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Carcinoma; Stage IV Prostate Cancer; Prostate Carcinoma Metastatic in the Bone
• Intervention / Treatment: Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Drug: Fluciclovine F18

Detailed Description

PRIMARY OBJECTIVES:

I. Abnormal fluciclovine F18 ([18F] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
• Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
• All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Exclusion Criteria:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
• Patients who require monitored anesthesia for PET scanning.
• Patients who are too claustrophobic to undergo PET scanning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Diagnostic (fluciclovine F18, PET/CT); Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

Procedure: Computed Tomography; Undergo PET/CT scan; Other Names: CT; CAT; CAT Scan; CT Scan; tomography; computerized tomography; Computerized Axial Tomography (CAT); Procedure: Positron Emission Tomography; Undergo PET/CT scan; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Drug: Fluciclovine F18; Given IV; Other Names: (18F)Fluciclovine; 18F-Fluciclovine; Fluciclovine (18F)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean standardized uptake value (SUVmean)	The primary analysis of SUVmean will be t-tests comparing the osteoblastic and osteolytic lesions. An additional analysis of the primary objective will be one way analysis of variance (ANOVA) with Tukey's post hoc analysis comparing all four lesion types (osteoblastic, osteolytic, marrow and mixed). As a secondary sensitivity analysis mixed effects models with a fixed effect for lesion type and a random patient effect will also be fit.	Up to 2 years
Maximum standardized uptake value (SUVmax)	The primary analysis of SUVmax will be t-tests comparing the osteoblastic and osteolytic lesions. An additional analysis of the primary objective will be one way analysis of variance (ANOVA) with Tukey's post hoc analysis comparing all four lesion types (osteoblastic, osteolytic, marrow and mixed). As a secondary sensitivity analysis mixed effects models with a fixed effect for lesion type and a random patient effect will also be fit.	Up to 2 years
Lesion uptake of 18F fluciclovine	Spearman correlation of lesion uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and 18F fluciclovine-positron emission tomography/computed tomography (PET/CT) at baseline and after 3 and 6 cycles of radium 223 will be calculated. The number of lesions identified by 99mTc-MDP bone scintigraphy alone, 18F fluciclovine- PET/CT alone, and both 99mTc-MDP bone scintigraphy and 18F fluciclovine- PET/CT will be tabulated.	Up to 6 months
Time to biochemical failure	Will be analyzed using standard survival analysis methods. Two binary variables will be constructed, by dividing the cohort into those that did and did not achieve a 25% or greater reduction in average (ave)SUVmax or ave SUVmean on 18F fluciclovine-PET/CT imaging after completion of all radiation therapy. Kaplan-Meier methods will be used for plotting and log rank tests will be used to determine whether either of these binary variable is predictive of increased time to biochemical failure.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: John Hoffman, MD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ACTUAL): February 3, 2022
• Study Completion (ACTUAL): February 3, 2022

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Carcinoma
• Other Study ID Numbers: HCI113970; NCI-2018-02083 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No