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

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ClinicalTrials.gov Identifier: NCT03707184
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Carcinoma Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Cancer Procedure: Computed Tomography Drug: Fluciclovine F18 Procedure: Positron Emission Tomography Phase 2

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 aveSUVmean 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : September 17, 2023
Estimated Study Completion Date : September 17, 2023

Resource links provided by the National Library of Medicine


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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Drug: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • 18F-Fluciclovine
  • Fluciclovine (18F)

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




Primary Outcome Measures :
  1. Mean standardized uptake value (SUVmean) [ Time Frame: Up to 2 years ]
    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.

  2. Maximum standardized uptake value (SUVmax) [ Time Frame: Up to 2 years ]
    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.

  3. Lesion uptake of 18F fluciclovine [ Time Frame: Up to 6 months ]
    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.

  4. Time to biochemical failure [ Time Frame: Up to 2 years ]
    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 aveSUVmean on18F 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707184


Contacts
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Contact: Paige Nielsen 801-585-5942 paige.nielsen@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Paige Nielsen    801-585-5942    paige.nielsen@hci.utah.edu   
Principal Investigator: John M. Hoffman, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: John Hoffman, MD Huntsman Cancer Institute/ University of Utah
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03707184    
Other Study ID Numbers: HCI113970
NCI-2018-02083 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases