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Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

Primary Purpose

Prostate Adenocarcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fluciclovine F18
Gallium Ga68-labeled PSMA-11
Positron Emission Tomography
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adenocarcinoma of the prostate, post radical-prostatectomy
  • Detectable prostate-specific antigen (PSA)
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
  • No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
  • No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
  • Willingness to undergo pelvic radiotherapy

Exclusion Criteria:

  • Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
  • Inability to undergo fluciclovine or Ga-PSMA PET-CT
  • Definitive findings of systemic metastasis on conventional imaging or biopsy
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Severe acute co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients

Sites / Locations

  • Grady Health System
  • Emory University Hospital/Winship Cancer Institute
  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (fluciclovine F18, PET/CT)

Arm II (68Ga-PSMA, PET/CT)

Arm Description

Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Outcomes

Primary Outcome Measures

Disease-free survival
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.

Secondary Outcome Measures

Decision to offer radiotherapy
Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Decision to treat pelvic nodes
Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Decision to boost between the initial and final treatment decisions
Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Prostate bed clinical target volume (CTV) and planning target volume (PTV)
Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography [PET]) and final (post-PET) radiation treatment plans.
PTV of the rectum (V65, V40)
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute genitourinary (GU) or gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.
PTV of the bladder (V65, V40)
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute GU or GI toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.

Full Information

First Posted
November 27, 2018
Last Updated
May 4, 2023
Sponsor
Emory University
Collaborators
Telix International Pty Ltd, National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03762759
Brief Title
Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Official Title
Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Telix International Pty Ltd, National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Detailed Description
PRIMARY OBJECTIVES I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation. II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine [18F]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making. III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes. ARM II: Patients receive 68Ga-PSMA IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (fluciclovine F18, PET/CT)
Arm Type
Experimental
Arm Description
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Arm Title
Arm II (68Ga-PSMA, PET/CT)
Arm Type
Active Comparator
Arm Description
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CT, CT scan, Computerized axial tomography, CAT, CAT scan
Intervention Description
Undergo PET/CT
Intervention Type
Drug
Intervention Name(s)
Fluciclovine F18
Other Intervention Name(s)
anti-3-[18F]FACBC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, FACBC, [18F]FACBC, Axumin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Gallium Ga68-labeled PSMA-11
Other Intervention Name(s)
68Ga-PSMA, 68Ga PSMA, [68Ga] Prostate-specific Membrane Antigen 11, 68Ga-DKFZ-PSMA-11, 68Ga-PSMA-HBED-CC
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
PET, PET scan, Proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT
Primary Outcome Measure Information:
Title
Disease-free survival
Description
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
Time Frame
Up to 2 years after study start
Secondary Outcome Measure Information:
Title
Decision to offer radiotherapy
Description
Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Time Frame
Up to 5 years after study start
Title
Decision to treat pelvic nodes
Description
Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Time Frame
Up to 5 years after study start
Title
Decision to boost between the initial and final treatment decisions
Description
Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
Time Frame
Up to 5 years after study start
Title
Prostate bed clinical target volume (CTV) and planning target volume (PTV)
Description
Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography [PET]) and final (post-PET) radiation treatment plans.
Time Frame
Up to 5 years after study start
Title
PTV of the rectum (V65, V40)
Description
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute genitourinary (GU) or gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.
Time Frame
Up to 5 years after study start
Title
PTV of the bladder (V65, V40)
Description
Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute GU or GI toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.
Time Frame
Up to 5 years after study start

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adenocarcinoma of the prostate, post radical-prostatectomy Detectable prostate-specific antigen (PSA) Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2 No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis Willingness to undergo pelvic radiotherapy Exclusion Criteria: Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy) Inability to undergo fluciclovine or Ga-PSMA PET-CT Definitive findings of systemic metastasis on conventional imaging or biopsy Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years Severe acute co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashesh Jani, MD, MSEE
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

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