Clinical Trials /

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

NCT03762759

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: IRB00106863
  • SECONDARY ID: NCI-2018-02702
  • SECONDARY ID: RAD4516-18
  • SECONDARY ID: R01CA226992
  • NCT ID: NCT03762759

Conditions

  • Prostate Adenocarcinoma

Interventions

DrugSynonymsArms
Fluciclovine F18anti-3-[18F]FACBC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, FACBC, [18F]FACBC, AxuminArm I (fluciclovine F18, PET/CT)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (fluciclovine F18, PET/CT)ExperimentalPatients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
  • Fluciclovine F18
Arm II (68Ga-PSMA, PET/CT)Active ComparatorPatients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Disease-free survival
    Time Frame:Up to 2 years after study start
    Safety Issue:
    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.

    Secondary Outcome Measures

    Measure:Decision to offer radiotherapy
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.
    Measure:Decision to treat pelvic nodes
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.
    Measure:Decision to boost between the initial and final treatment decisions
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.
    Measure:Prostate bed clinical target volume (CTV) and planning target volume (PTV)
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.
    Measure:PTV of the rectum (V65, V40)
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.
    Measure:PTV of the bladder (V65, V40)
    Time Frame:Up to 5 years after study start
    Safety Issue:
    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.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Emory University

    Last Updated

    July 25, 2019