Axumin® (fluciclovine F 18) injection patient case studies

Featured Case Study

High-risk surgical features, rapidly rising PSA post RARP (Robotic Assisted Radical Prostatectomy)

Provided by:

Steven Eric Finkelstein, MD, DABR, FACRO
Florida Cancer Affiliates
The US Oncology Network

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    Provided by:

    Froylan Gonzalez, MD
    Board Certified Urologist
    Georgia Urology
    Canton, GA

      Clinical history:

      • Age at diagnosis: 74
      • Date of diagnosis: 3/2017
      • PSA at diagnosis: 6.0 ng/mL
      • Gleason score: 4+4=8
      • Initial treatment: Robot assisted radical prostatectomy (6/2017)
      • Final pathology: 4+3=7 with tertiary pattern 5 + perineurial invasion; seminal vesicle invasion and extra-prostatic extension, tumor present in both lobes, pT3c, Nx, Mx
      • Post treatment nadir PSA: 0.11 ng/mL (9/2017)

      PSA at recurrence:

      • 1.29 ng/mL (1/2018)
      • 1.88 ng/mL (2/2018)

      Conventional imaging results:

      • MRI (2/2018):
        • Small pelvic lymphocoele
        • Diffuse urinary bladder wall thickening may be sequela of prior chronic outlet obstruction
        • No lymphadenopathy
        • Small bilateral hydroceles
        • No MR evidence of recurrent prostate cancer in the surgical bed and visualized pelvis

      Planned clinical management:

      • Radiotherapy to pelvic nodes with boost to prostatic fossa and short-course ADT

      Details associated with decision to refer patient for an Axumin scan:

      • Localize site of recurrence (3/2018)

      Axumin imaging interpretation:

      • Positive Axumin PET/CT: demonstrated asymmetric intense fluciclovine F 18 uptake localized to a sclerotic lesion in the middle right iliac bone
      • Findings consistent with an isolated osseous metastasis

      Final management plan:

      • Stereotactic body radiation therapy to isolated iliac metastases plus short-course ADT
      • PSA to be closely monitored
      Axumin image
      Axumin image

      Provided by:

      Michael Kipper, MD
      Nuclear Medicine Physician
      Genesis Research LLC
      San Diego, CA

      Paul Dato, MD
      Urologist
      Genesis Research LLC
      San Diego, CA

        Clinical history:

        • Age at diagnosis: 71
        • Date of diagnosis: 3/2007
        • PSA at diagnosis: 5.9 ng/mL
        • Gleason score: 4+3=7
        • Initial treatment: Radiotherapy - EBRT/IMRT (5/2007)
        • Clinical stage: cT2a, M0, N0
        • Post treatment nadir PSA: 0.7 ng/mL, remained stable until 1/2014

        Additional treatment and PSA draws:

        • PSA: 1.1 ng/mL (1/2014)
        • Received short term leuprolide (8/2014) + docetaxel (9/2014)
        • Progressive PSA rise to 10.8 ng/mL (1/2016)
        • PSA: 8.6 ng/mL (2/2016)
        • PSA: 7.8 ng/mL (6/2016)

        Conventional imaging results:

        • Negative CT scan (6/2016)
          • Retroperitoneal lymph nodes, other lymph nodes, prostate and prostate bed

        Planned clinical management:

        • Androgen deprivation therapy (ADT)

        Details associated with decision to refer patient for an Axumin scan:

        • Rising PSA post-radiotherapy

        Axumin imaging interpretation:

        • Positive Axumin PET/CT: Abnormal fluciclovine F 18 activity demonstrated in the right mid-peripheral zone of the prostate with SUVmax of 3.4 (biopsy confirmed on 8/2016)

        Final management plan:

        • Salvage SBRT (9/2016)

        Clinical follow-up:

        • PSA: 1.1 ng/mL (1/2017)
        • PSA: 0.3 ng/mL (3/2019)
        • Continued observation
        Axumin imaging revealed right mid peripheral zone malignant uptake (7/2016) Prostate Lesion SUV(bw)max : 3.4 Marrow (L3) Reference SUV(bw)mean: 2.6

        Axumin imaging revealed right mid peripheral zone malignant uptake (7/2016) 
        Prostate Lesion SUV(bw)max : 3.4 
        Marrow (L3) Reference SUV(bw)mean: 2.6

        Axumin imaging revealed right mid peripheral zone malignant uptake (7/2016) Prostate Lesion SUV(bw)max : 3.4 Marrow (L3) Reference SUV(bw)mean: 2.6

        Provided by:

        David Josephson, MD, FACS
        Tower Urology Institute for Minimally Invasive and Robotic Surgery
        Attending Surgeon
        Cedars Sinai Medical Center
        Los Angeles, CA

        Jennifer Kujak, MD
        Director of Oncological Imaging
        RadNet Los Angeles
        Los Angeles, CA

          Clinical history:

          • Age at diagnosis: 65
          • Date of diagnosis: 10/2014
          • PSA at diagnosis: 5.6 ng/mL
          • Gleason score: 3+4=7
          • Initial treatment: Radical prostatectomy (11/2014)  
          • Final pathology: pT3b, N0, M0; 4+3=7 with tertiary pattern 5; extraprostatic extension, positive margins and bilateral seminal vesicles
          • Post treatment nadir PSA: <0.10 ng/mL (1/2015); undetectable

          1st PSA Recurrence and treatment:

          • PSA: 0.48 ng/mL (4/2015)
          • Salvage radiotherapy (11/2015)
          • PSA: 0.50 ng/mL (2/2016)

          2nd PSA Recurrence:

          • PSA: 2.2 ng/mL (8/2016)

          Conventional imaging results:

          • Negative Tc-99m bone scan (9/2016)
          • Negative MRI of prostate and prostate bed (9/2016)

          Planned clinical management:

          • Salvage radiotherapy to the prostate bed

          Details associated with decision to refer patient for an Axumin scan:

          • Rising PSA post-prostatectomy and salvage radiotherapy
          • PSA at time of Axumin scan: 7.0 ng/mL (9/2016)

          Axumin imaging interpretation:

          • Positive Axumin PET/CT: Fluciclovine F 18 uptake demonstrated in para-caval and right retrocrural lymph nodes (10/2016)

          Final management plan:

          • Bicalutamide and leuprolide

          Clinical follow-up:

          • PSA 0.1 ng/mL (2/2017)
          Axumin imaging revealed para-caval lymph node malignant uptake Lymph Node SUV(bw)max : 2.7 Blood pool SUV(bw)mean :  1.0

          Axumin imaging revealed para-caval lymph node malignant uptake
          Lymph Node SUV(bw)max : 2.7
          Blood pool SUV(bw)mean :  1.0

          Axumin imaging revealed para-caval lymph node malignant uptake Lymph Node SUV(bw)max : 2.7 Blood pool SUV(bw)mean :  1.0
          Axumin imaging revealed retrocrural lymph node malignant uptake Lymph Node SUV(bw)max : 3.6 Blood pool SUV(bw)mean : 1.0

          Axumin imaging revealed retrocrural lymph node malignant uptake
          Lymph Node SUV(bw)max : 3.6
          Blood pool SUV(bw)mean : 1.0

          Axumin imaging revealed retrocrural lymph node malignant uptake Lymph Node SUV(bw)max : 3.6 Blood pool SUV(bw)mean : 1.0

          Provided by:

          Barry A. Siegel, MD
          Professor, Sr. Vice Chair, and Chief
          Division of Nuclear Medicine,
          Department of Radiology
          Washington University
          St. Louis, MO

          Jeff M. Michalski, MD
          Vice Chairman, Radiation Oncology
          Chief, Genitourinary Service
          Washington University
          St. Louis, MO

            Clinical history:

            • Age at diagnosis: 65
            • Date of diagnosis: 12/2005
            • PSA at diagnosis: Unknown
            • Gleason score: 8
            • Initial treatment: Radical prostatectomy (2/2006)
            • Final pathology: pT2C, N0, M0
            • Post treatment nadir PSA: 0.10 ng/mL (10/2006); remained undetectable through 8/2010

            PSA at consultation:

            • 4.5 ng/mL (11/2016)

            Conventional imaging results:

            • Negative Tc-99m bone scan (1/2017)

            Planned clinical management:

            • Salvage radiation to the prostatectomy bed

            Details associated with decision to refer patients for an Axumin scan:

            • Rising PSA 10+ years post-prostatectomy
            • PSA at time of Axumin scan: 4.6 ng/mL (3/2017)

             

            Axumin imaging interpretation:

            • Positive Axumin PET/CT: Fluciclovine F 18 uptake demonstrated in the left seminal vesicle and 8mm lymph node along the superior left pelvic side wall, adjacent to a surgical clip

            Final management plan:

            • With delineation of disease outside of the intended radiotherapy field, the management plan was revised to include pelvic radiotherapy with boost to Axumin avid disease, and androgen deprivation

            Clinical follow-up:

            • PSA on available short-term follow-up dropped significantly to 0.1 ng/mL (9/2017)
            Axumin imaging revealed avid disease within the left seminal vesicle (3/2017)

            Axumin imaging revealed avid disease within the left seminal vesicle (3/2017)

            Axumin imaging revealed avid disease within the left seminal vesicle (3/2017)
            Axumin imaging revealed avid 8mm lymph node along the superior left pelvic side wall, adjacent to a surgical clip (3/2017)

            Axumin imaging revealed avid 8mm lymph node along the superior left pelvic side wall, adjacent to a surgical clip (3/2017)

            Axumin imaging revealed avid 8mm lymph node along the superior left pelvic side wall, adjacent to a surgical clip (3/2017)

            Provided by:

            Jonathan Tward, MD, PhD
            Rudolph P. and Edna S. Reese Endowed Research Professor
            Associate Professor of Radiation Oncology
            Co-Leader, Genitourinary Malignancies Disease-Oriented Team
            Huntsman Cancer Institute at the University of Utah

              Clinical history:

              • Age at diagnosis: 60
              • Date of diagnosis: 11/2014
              • PSA at diagnosis: 3.0 ng/mL
              • Gleason score: 4+3
              • Initial treatment: Whole gland HIFU (1/2015)
              • Post treatment nadir PSA: 0.3 ng/mL

              PSA at recurrence:

              • 1.3 ng/mL (2/2016)

              Subsequent PSA levels:

              • 1.90 ng/mL (5/2016)
              • 2.40 ng/mL (7/2016)
              • 2.70 ng/mL (9/2016)
              • 4.95 ng/mL (1/2017)
              • 7.10 ng/mL (5/2017)

               

              Conventional imaging results:

              • MRI Prostate Protocol: Significantly limited exam secondary to severe prostatic atrophy and loss of zonal anatomy related to reported prior HIFU without definitive MRI findings to suggest prostate adenocarcinoma.
              • Bone Scan: Negative

              Planned clinical management:

              • Considered for salvage prostatectomy, brachytherapy pending imaging studies.

              Axumin imaging interpretation:

              • Positive Axumin scan with focal uptake is considered nonspecific but concerning for disease versus hypertrophy in the appropriate clinical setting.

              Final management plan:

              • After biopsy confirmation, patient was taken to the OR on 12/21/2017 for salvage whole gland brachytherapy.

              Clinical follow-up:

              • PSA
                • Pre-Salvage: 7.1 ng/mL
                • Post-Salvage (1.5 years): 0.03 ng/mL
              • No evidence of disease approximately 1.5 years after salvage.
              Focal hyperattenuating nodule within the right lobe of the prostate gland seen with a max SUV of 5.3

              Provided by:

              Barry A. Siegel, MD
              Professor, Sr. Vice Chair, and Chief
              Division of Nuclear Medicine, Department of Radiology
              Washington University
              St. Louis, MO

              Jeff M. Michalski, MD
              Vice Chairman, Radiation Oncology
              Chief, Genitourinary Service
              Washington University
              St. Louis, MO

                Clinical history:

                • Age at diagnosis: 72
                • Date of diagnosis: 1/2013
                • PSA at diagnosis: 4.0 ng/mL
                • Gleason score: 7
                • Initial treatment: Radical prostatectomy (3/2013)
                • Final pathology: pT2c, N0, MX
                • Post treatment nadir PSA: 0.2 ng/mL (5/2013)

                PSA at recurrence:

                • 0.2 ng/mL (6/2015)
                • 0.4 ng/mL (8/2016)

                Conventional imaging results:

                • Negative bone scan (8/2016)
                • Equivocal MRI of prostate and prostate bed (8/2016)

                Planned clinical management:

                • ADT and salvage radiotherapy to the prostate bed

                 

                Axumin imaging interpretation:

                • Positive Axumin PET/CT: Axumin scan demonstrated fluciclovine F 18 activity in right illium and left prostatectomy bed (8/2016)

                Final management plan:

                • ADT and salvage radiotherapy to the prostate bed and whole pelvis with boost to areas guided by Axumin uptake; leuprolide (8/2016); EBRT/IMRT (10/2016); EBRT/IMRT (11/2016)

                Clinical follow-up:

                • PSA response: <0.1 ng/mL (1/2017)
                Axumin imaging revealed right Ilium skeletal uptake (8/2016) Rt. Ilium Lesion SUV(bw)max :  6.0 Marrow (L3) SUV(bw)mean :  3.0

                Axumin imaging revealed right Ilium skeletal uptake (8/2016)
                Rt. Ilium Lesion SUV(bw)max :  6.0
                Marrow (L3) SUV(bw)mean :  3.0

                AxAxumin imaging revealed right Ilium skeletal uptake (8/2016) Rt. Ilium Lesion SUV(bw)max :  6.0 Marrow (L3) SUV(bw)mean :  3.0
                Axumin imaging revealed left prostatectomy bed uptake (8/2016) Prostatectomy Bed Lesion SUV(bw)max : 4.3 Marrow (L3) SUV(bw)mean : 3.1

                Axumin imaging revealed left prostatectomy bed uptake (8/2016)
                Prostatectomy Bed Lesion SUV(bw)max : 4.3
                Marrow (L3) SUV(bw)mean : 3.1

                Axumin imaging revealed left prostatectomy bed uptake (8/2016) Prostatectomy Bed Lesion SUV(bw)max : 4.3 Marrow (L3) SUV(bw)mean : 3.1

                Provided by:

                Michael Kipper, MD
                Nuclear Medicine Physician
                Genesis Research LLC
                San Diego, CA

                Paul Dato, MD
                Urologist
                Genesis Research LLC
                San Diego, CA

                  Clinical history:

                  • Age at diagnosis: 63
                  • Date of diagnosis: 11/2015
                  • PSA at diagnosis: 10.3 ng/mL
                  • Gleason score: 4+4=8
                  • Initial treatment: Radical prostatectomy (3/2016)
                  • Final pathology: pT3b, N1, M0
                  • Post treatment nadir PSA: 6.0 ng/mL (5/2016)
                  • Adjuvant treatment: leuprolide (6/2016)
                  • PSA 1.1 ng/mL (9/2016)

                  Conventional imaging results:

                  • Negative bone scan (9/2016)
                  • Negative CT scan (9/2016)

                  Additional PSA draws:

                  • 0.9 ng/mL (10/2016)
                  • 1.0 ng/mL (11/2016)

                  Planned clinical management:

                  • Salvage radiotherapy to the prostate bed and whole pelvis

                  Details associated with decision to refer patient for an Axumin scan:

                  • To investigate if nodal disease remained since PSA never became undetectable

                  Axumin imaging interpretation:

                  • Positive Axumin PET/CT: Fluciclovine F 18 uptake in left obturator lymph node (11/2016)

                  Final management plan:

                  • Salvage radiotherapy to the prostate bed and whole pelvis with boost to areas guided by Axumin imaging (3/2017); initiated ADT (leuprolide) for 24 months

                  Clinical follow-up:

                  • PSA: <0.1 ng/mL (12/2017)
                  Axumin imaging revealed left obturator lymph node positive uptake (11/2016) Lymph Node SUV (bw)max : 3.2

                  Axumin imaging revealed left obturator lymph node positive uptake (11/2016)
                  Lymph Node SUV (bw)max : 3.2

                  Axumin imaging revealed left obturator lymph node positive uptake (11/2016) Lymph Node SUV (bw)max : 3.2

                  Provided by:

                  David Josephson, MD, FACS
                  Tower Urology Institute for Minimally Invasive and Robotic Surgery
                  Attending Surgeon
                  Cedars Sinai Medical Center
                  Los Angeles, CA

                  Jennifer Kujak, MD
                  Director of Oncological Imaging
                  RadNet Los Angeles
                  Los Angeles, CA

                    Clinical history:

                    • Age at diagnosis: 71
                    • Date of diagnosis: 11/2008
                    • PSA at diagnosis: 3.87 ng/mL
                    • Gleason score: 4+3=7
                    • Initial treatment: Radical prostatectomy (12/2008)  
                    • Final pathology: pT2c, N0, M0; no extra prostatic and perineural extension; negative margins and seminal vesicles
                    • Post treatment nadir PSA: <0.10 ng/mL (12/2011)

                    PSA at recurrence:

                    • 2.66 ng/mL (1/2016)
                    • 3.40 ng/mL (6/2016)

                    Conventional imaging results:

                    • Negative CT scan (5/2016)
                    • Negative Tc-99m bone scan (6/2016)

                    Planned clinical management:

                    • Salvage radiotherapy to the prostate bed

                    Axumin imaging interpretation:

                    • Positive Axumin PET/CT: Fluciclovine F 18 uptake in anterior peri-rectal lymph node (6/2016)

                    Final management plan:

                    • Salvage radiotherapy to the prostate bed with boost to areas guided by Axumin uptake

                    Clinical follow-up:

                    • Leuprolide (7/2016)
                      • PSA: 0.30 ng/mL (8/2016)
                    • EBRT/IMRT (8/2016)
                      • PSA: <0.10 ng/mL (10/2016)
                      • PSA: <0.10 ng/mL (12/2016)
                    • Undetectable at follow up
                    Axumin imaging revealed interior peri-rectal malignant lymph node uptake (6/2016) Lymph Node SUV(bw)max : 2.8 Blood pool SUV(bw)mean : 2.2

                    Axumin imaging revealed interior peri-rectal malignant lymph node uptake (6/2016)
                    Lymph Node SUV(bw)max : 2.8
                    Blood pool SUV(bw)mean : 2.2

                    Axumin imaging revealed interior peri-rectal malignant lymph node uptake (6/2016) Lymph Node SUV(bw)max : 2.8 Blood pool SUV(bw)mean : 2.2

                    Provided by:

                    Steven Eric Finkelstein, MD, DABR, FACRO
                    Florida Cancer Affiliates
                    The US Oncology Network

                      Clinical history:

                      • Age at diagnosis: 67
                      • Date of diagnosis: 2018
                      • PSA at diagnosis: 4.4 ng/mL
                      • Gleason score: 4+5
                      • Initial treatment: Robotic assisted laparoscopic radical prostatectomy and bilateral pelvic lymphadenectomy
                      • Final pathology: pT3pN0M0, stage IIB; Adverse features, including positive right bladder neck margin, focal extraprostatic extension, and diffuse perineural angiolymphatic invasion
                      • Post treatment nadir PSA: 0.15 ng/mL

                      PSA at recurrence:

                      • 0.9 ng/mL (8/2018)

                      Conventional imaging results:

                      • NaF bone scan: negative (2018)

                      Planned clinical management:

                      • Post-prostatectomy external radiation treatment (XRT)

                      Details associated with decision to refer patients for an Axumin scan:

                      • Scan will inform XRT volume planning

                      Axumin imaging interpretation:

                      • Positive Axumin PET/CT: Increased tracer uptake in the left pelvis
                      • No evidence of distant disease

                      Final management plan:

                      • XRT planning adjusted to incorporate Axumin PET/CT findings
                      Negative NaF PET/CT Bone Scan

                      Negative NaF PET/CT Bone Scan

                      Positive Axumin PET/CT scan

                      Positive Axumin PET/CT scan

                      IMRT and daily IGRT to 45.0 0Gy/1.8 Gy/25 treatments followed by an additional 23.4 Gy/1.8 Gy/13 treatments to the prostate bed to achieve a total treatment dose of 68.4 Gy/1.8 Gy/38 treatments

                      IMRT and daily IGRT to 45.0 Gy/1.8 Gy/25 treatments followed by an additional 23.4 Gy/1.8 Gy/13 treatments to the prostate bed to achieve a total treatment dose of 68.4 Gy/1.8 Gy/38 treatments

                      These case studies are being provided to you as examples of the images and information available following Axumin PET/CT imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The responsibility for the accurate and timely acquisition and interpretation of images using Axumin PET/CT scanning rests with the nuclear medicine physician or radiologist supervising the PET/CT imaging facility. Axumin is not indicated for directing or changing patient management. These case studies are not intended to substitute for the independent medical judgment of the physician(s) responsible for the individual patient’s management, nor are they a guarantee of any specific clinical results. Incidental findings are noted in some of the cases, as examples of potential, unanticipated abnormalities that may be identified during interpretation of Axumin images. The diagnostic efficacy of Axumin for the identification of these incidental abnormalities has not been established and confirmatory testing may be considered appropriate. These case studies are post marketing, on label, and, at present, there is nothing to suggest that adverse events potentially change Axumin’s safety profile.

                      INDICATION

                      Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

                      IMPORTANT SAFETY INFORMATION

                      • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
                      • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
                      • Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
                      • Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

                      To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

                      Please see Axumin full Prescribing Information.