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

Stage IV Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707184
• Other study ID #: HCI113970
• Secondary ID: NCI-2018-02083
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2018
• Est. completion date: February 3, 2022

Study information

• Verified date: April 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Prostate Carcinoma
• Prostate Carcinoma Metastatic in the Bone
• Prostatic Neoplasms
• Stage IV Prostate Cancer

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Drug:
• Fluciclovine F18
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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