PSMA-targeted radiopharmaceuticals: An evolving approach to prostate cancer management

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    Faculty & Disclosures
    Prof. Oliver Sartor

    Mayo Clinic, Rochester, MN, USA

    Prof. Oliver Sartor is director of radiopharmaceutical trials and professor of medicine, urology and oncology in the Department of Medical Oncology at the Mayo Clinic, Rochester, MN, USA. read more

    His medical practice and research have focused on prostate cancer since 1990 when he finished a medical oncology fellowship at the National Cancer Institute (NCI). After serving as the associate dean for oncology and medical director of the Tulane Cancer Center, he moved to the Mayo Clinic in April 2023, where he now works in a multidisciplinary environment intersecting with urology, nuclear medicine and medical oncology. He serves as the vice-chair of the genitourinary cancer committee of NRG Oncology, a national cancer research group focused on radiotherapies. Past endeavours have included terms as a member of the NCI Board of Scientific Counselors (Clinical Sciences and Epidemiology) and as a faculty member at the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute at Harvard. He has also served as past editor-in-chief of the peer-reviewed journal Clinical Genitourinary Cancers.

    He has published over 500 manuscripts and led or co-led multiple national and international clinical studies, including multiple phase III studies in prostate cancer (samarium-153 ethylene diamine tetra methylene phosphonate [EDTMP], cabazitaxel, radium-223 and lutetium-177-prostate specific membrane antigen [PSMA]-617). In addition to therapeutic studies, he has long been involved with translational and scientific studies in patients with prostate cancer. The issues related to prostate cancer have many complex genetic and non-genetic changes and, in these projects, he has been a catalyst for helping to understand how prostate cancer develops and progresses. He has lectured widely, and at the last count had given invited lectures in 33 countries.

    Prof. Oliver Sartor discloses: Advisory board or panel fees from ArtBio, Clarity, Convergent and NorthStar. Consultant fees from Advanced Accelerator Applications, a Novartis company, Amgen, ArtBio, Astellas, AstraZeneca, Bayer, Blue Earth Diagnostics, Clarity, Convergent, EMD Serono, Fusion, Genzyme, Hengrui, Isotopen Technologien München, Janssen, Merck, Myovant, Myriad, Noria Therapeutics, NorthStar, Novartis, Point BioPharma, Pfizer, Ratio Therapeutics, Sanofi, Telix and Theragnostics. Grants/research support from Advanced Accelerator Applications, a Novartis company, Amgen, AstraZeneca, Bayer, Invitae, Janssen, Lantheus, Merck and Sanofi. Stock/shareholder (self-managed) AbbVie, ArtBio, Cardinal Health, Convergent, Eli Lilly, Fusion Pharmaceuticals, Point Biopharma, Ratio Therapeutics, Rayze, Telix and United Health Group.
    Prof. Francesco Ceci

    European Institute of Oncology, IRCCS, Milan, Italy

    Prof. Francesco Ceci is the director of the Division of Nuclear Medicine at the European Institute of Oncology, Scientific Institute for Research, Hospitalization and Healthcare, Milan, Italy, and professor of nuclear medicine in the Department of Oncology and Hemato-Oncology at the University of Milan. read more

    His clinical focus is in the field of molecular imaging and radioligand therapy. His clinical research activity concerns prostate-specific membrane antigen (PSMA) positron emission tomography and lutetium-PSMA therapy in male genitourinary tumours, and clinical applications in the field of radiomics and artificial intelligence in the main oncological and onco-haematological pathologies.

    He is the author of numerous publications in international scientific journals and actively collaborates with many research centres and universities in Europe and the USA.

    Prof. Francesco Ceci discloses: Advisory board or panel fees from Novartis and Telix (relationships terminated). Consultant fees from Curium and Novartis (relationships terminated). Other financial or material support from Bayer, Curium, Janssen Oncology, Novartis, Radmetrix and Telix (relationships terminated).
    Dr Heather Jacene

    Dana-Farber Cancer Institute, Boston, MA, USA

    Dr Heather Jacine is a senior physician and the clinical director of nuclear medicine at the Dana-Farber Cancer Institute, Boston, MA, USA. She is also the associate programme director at Brigham and Women’s Joint Program in Nuclear Medicine and associate professor of radiology at Harvard Medical School. read more

    She completed her residency and fellowship in nuclear medicine and positron emission tomography/computed tomography (PET/CT) at Johns Hopkins University, Baltimore, MD. 

    Dr Jacene has served as a director on the American Board of Nuclear Medicine and on numerous committees within the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Her current positions include

    chair of the Scientific Program Committee and chair of the Quality of Practice Domain for the SNMMI.

    Dr Jacene has vast expertise in the interpretation of oncology PET/CT scans and in treating various tumour types with radiopharmaceutical therapy. She extends this expertise to her research, which focuses on the use of fluorodeoxyglucose PET/CT and other novel tracers for characterizing and monitoring the response of cancer to therapy, as well as the use of radiopharmaceutical therapy.

    She has authored over 85 peer-reviewed publications, as well as many reviews and book chapters.

    Dr Heather Jacene discloses: Advisory board or panel fees from Spectrum Dynamics Medical Ltd. Consultant fees from Blue Earth Diagnostics. Grant/research support fees from GTx and Siemens.
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    This icon indicates there is a poll question. Click it when you see it to interact with your peers.

    Poll

    Are baseline NLR and ALC values useful when selecting radioligand therapy? 

    NLR, neutrophil-to-lymphocyte ratio; ALC, absolute lymphocyte count

    Submit your answer to see the results

    Not at all useful
       
    Somewhat useful
       
    Useful
       
    Uncertain, more data needed
       
     
     
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    Tutorial

    This icon indicates there is a poll question. Click it when you see it to interact with your peers.

    Poll

    What do the data say most about sequential use of radioligand therapy in mCRPC?

    Based on Sun et al. Abstract 1822P. ESMO 2023. mCRCP, metastatic castration-resistant prostate cancer.

    Submit your answer to see the results

    Sequential use is safe and efficacy is maintained
       
    Order in which radiopharmaceuticals can be used
       
    Number of times they can be used over time
       
    Organ toxicities associated with cumulative use
       
     
     
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    Tutorial

    This icon indicates there is a poll question. Click it when you see it to interact with your peers.

    Poll

    What is your key takeaway from the PMSAfore trial on the use of 177Lu-PSMA-617?

    ARPI, androgen receptor pathway inhibition; HRQoL, health-related quality of life; OS, overall survival; SOC, standard of care

    Submit your answer to see the results

    Side effects are similar to ARPIs and less than chemotherapy
       
    OS results are confounded and too early to quantify survival benefit
       
    Offers improved HRQoL compared with ARPIs
       
    Will lead to its earlier use and a new SOC in the pre-taxane setting
       
     
     
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    Prostate Cancer, Genitourinary Cancer, Radiotherapy CE/CME accredited

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    Our faculty interpret key data from the congress, complimented by an expert panel discussing what has been presented. Close

    PSMA-targeted radiopharmaceuticals: An evolving approach to prostate cancer management

    Learning Objectives

    After watching this activity, participants should be better able to:

    • Describe potential strategies to refine selection of patients with advanced prostate cancer for treatment with PSMA-targeting radiopharmaceuticals
    • Outline how the latest data for PSMA-targeting radiopharmaceuticals may impact the timing of their use in patients with advanced prostate cancer
    • Analyse the latest data on radiopharmaceuticals in advanced prostate cancer, including combination strategies and novel agents in clinical development
    Overview

    In this activity, the key data on the use of prostate-specific membrane antigen-targeted radiopharmaceuticals in prostate cancer presented at ESMO 2023 will be reviewed by three experts in prostate cancer. These experts will discuss the potential implications of these data on clinical practice.

    This activity was filmed following the ESMO 2023 Congress (Madrid, Spain, 20–24 October 2023).

    This activity is jointly provided by USF Health and touchIME. read more

    Target Audience

    This activity has been designed to meet the educational needs of oncologists, prostate cancer specialists, urologists and radiation oncologists involved in the management of prostate cancer.

    Disclosures

    USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty

    Prof. Oliver Sartor discloses: Advisory board or panel fees from ArtBio, Clarity, Convergent and NorthStar. Consultant fees from Advanced Accelerator Applications, a Novartis company, Amgen, ArtBio, Astellas, AstraZeneca, Bayer, Blue Earth Diagnostics, Clarity, Convergent, EMD Serono, Fusion, Genzyme, Hengrui, Isotopen Technologien München, Janssen, Merck, Myovant, Myriad, Noria Therapeutics, NorthStar, Novartis, Point BioPharma, Pfizer, Ratio Therapeutics, Sanofi, Telix and Theragnostics. Grants/research support from Advanced Accelerator Applications, a Novartis company, Amgen, AstraZeneca, Bayer, Invitae, Janssen, Lantheus, Merck and Sanofi. Stock/shareholder (self-managed) AbbVie, ArtBio, Cardinal Health, Convergent, Eli Lilly, Fusion Pharmaceuticals, Point Biopharma, Ratio Therapeutics, Rayze, Telix and United Health Group.

    Prof. Francesco Ceci discloses: Advisory board or panel fees from Novartis and Telix (relationships terminated). Consultant fees from Curium and Novartis (relationships terminated). Other financial or material support from Bayer, Curium, Janssen Oncology, Novartis, Radmetrix and Telix (relationships terminated).

    Dr Heather Jacene discloses: Advisory board or panel fees from Spectrum Dynamics Medical Ltd. Consultant fees from Blue Earth Diagnostics. Grant/research support fees from GTx and Siemens.

    Content Reviewer

    Alicia Ann Canalejo, MSN, ARNP-C has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Contributors

    Kathy Day has no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

    In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

    If you have questions regarding credit please contact cpdsupport@usf.edu.

    Accreditations

    Physicians

    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 1.0 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Date of original release: 27 November 2023. Date credits expire: 27 November 2024.

    If you have any questions regarding credit please contact cpdsupport@usf.edu.

    This activity is CE/CME accredited

    To obtain the credit(s) from this activity, please complete this post-activity test.

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    Topics covered in this activity

    Prostate Cancer / Genitourinary Cancer / Radiotherapy
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    This Activity Is Funded By:

    An independent medical education grant from Advanced Accelerator Applications. This activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 27 November 2023. Date credits expire: 27 November 2024.

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    PSMA-targeted radiopharmaceuticals: An evolving approach to prostate cancer management
    1.0 CE/CME credit
    Question 1/5
    Based on post hoc analyses evaluating the prognostic worth of NLR and lymphopenia in the VISION study cohort, which baseline NLR and ALC values may be associated with worst outcomes for OS and rPFS and can be used when counseling patients on whether to add 177Lu-PSMA-617 to the SOC?

    ALC, absolute lymphocyte count; NLR, neutrophil-to-lymphocyte ratio; OS, overall survival; PSMA, prostate-specific membrane antigen; rPFS, radiographic progression-free survival; SOC, standard of care.

    Post hoc analyses of the prognostic worth of NLR and lymphopenia in the VISION study cohort demonstrated that baseline ALC <1.0×103/μL was associated with a shorter median rPFS compared with ALC ≥1.0×103/μL (rPFS 8.0 months vs 10.8 months, respectively) in patients treated with 177Lu-PSMA-617 plus SOC. Baseline NLR ≥3 and ALC <1.0×103/μL were prognostic for worse OS and rPFS in patients with mCRPC regardless of treatment received. 

    Abbreviations

    ALC, absolute lymphocyte count; mCRPC, metastatic castration-resistant prostate cancer; NLR, neutrophil-to-lymphocyte ratio; OS, overall survival; PSMA, prostate-specific membrane antigen; rPFS, radiographic progression-free survival; SOC, standard of care.

    Reference

    Wei X, et al. Presented at: ESMO Congress 2023, Madrid, Spain. 20–24 October 2023. Abstr 1838P.

    Question 2/5
    Your patient with mCRPC is about to start 225Ac-J591 TAT as part of a clinical trial. They are concerned about the impact their previous management with 223Ra may have on the effect of treatment with 225Ac-J591. How would you advise this patient in terms of what clinical outcomes you might expect with 225Ac-J591 in this patient compared with their counterparts who have not received prior 223Ra?

    mCRPC, metastatic castration-resistant prostate cancer; OS, overall survival; PFS, progression-free survival; PSA, prostate-specific antigen; TAT, targeted alpha therapy.

    Results from a retrospective combined analysis of data from patients with mCRPC receiving 225Ac-J591 TAT in prospective clinical trials (NCT03276572; NCT04506567; NCT04886986; NCT04946370) concluded that there were no significant differences in efficacy outcomes for patients treated with 225Ac-J591 who had received prior 223Ra, compared with patients who had not; biochemical progression-free survival: 3.93 vs 4.83 months (p=0.39); overall survival: 10.7 vs 17.3 months (p=0.12); PSA50-RR: 53% vs 57% (p=0.8).

    Abbreviations

    mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSA50-RR, PSA50 response rate (≥50% reduction in PSA levels from baseline); TAT, targeted alpha therapy.

    Reference

    Sun M, et al. Presented at: ESMO Congress 2023, Madrid, Spain. 20–24 October 2023. Abstr 1822P.

    Question 3/5
    After returning from ESMO 2023, you are discussing treatment plans for a patient with taxane-naive, PSMA-positive mCRPC who is eligible for 177Lu-PSMA therapy. A colleague asks whether the patient would benefit from docetaxel prior to receiving 177Lu-PSMA therapy. Which of the following statements would you use to support a decision to prescribe 177Lu-PSMA (should this option be available), based on the outcomes from the first interim analyses of the phase II data?

    ESMO, European Society for Medical Oncology; mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSA50-RR, PSA50 response rate; PSMA, prostate-specific membrane antigen.

    The first interim analysis of a small, single-centre, phase II study (IRST-185.03) concluded that after a median follow-up of 28.8 months, 177Lu-PSMA-617 achieved favourable clinical outcomes in the pre-taxane setting compared with post-taxane: PSA50-RR: 54.8% vs 35%; median progression-free survival: 8.5 vs 6.0 months (HR 0.65, 95% CI 0.44–0.95; p=0.038); median overall survival: 35.1 vs 12.6 months (HR 0.31, 95% CI 0.19–0.49; p=0.0002). No grade 3 adverse events were reported in the pre-taxane cohort.

    Abbreviations

    CI, confidence interval; HR, hazard ratio; PSA, prostate-specific antigen; PSA50-RR, PSA50 response rate; PSMA, prostate-specific membrane antigen.

    Reference

    Giunta EF, et al. Presented at: ESMO Congress 2023, Madrid, Spain. 20–24 October 2023. Abstr 1826P.

    Question 4/5
    You have a patient who is enrolled in the PSMAfore study. At their latest follow-up appointment they say that they have heard that the second interim analysis results have been released and they would like to know about the progression-free survival data. How would you describe the results to this patient?

    ARPI, androgen receptor pathway inhibition; PSMA, prostate-specific membrane antigen; rPFS, radiographic progression-free survival.

    PSMAfore is a phase III clinical trial comparing 177Lu-PSMA-617 with ARPI change in taxane-naive patients with metastatic castration-resistant prostate cancer. Data from the second interim analysis demonstrated a substantially longer radiographic progression-free survival in patients receiving 177Lu-PSMA-617 compared with ARPI change (12.02 months vs 5.59 months, respectively; HR 0.43, 95% CI 0.33–0.54).

    Abbreviations

    ARPI, androgen receptor pathway inhibition; CI, confidence interval; HR, hazard ratio; PSMA, prostate-specific membrane antigen.

    Reference

    Sartor O, et al. Presented at ESMO Congress 2023, 20–24 October 2023. Madrid, Spain. Abstr LBA13.

    Question 5/5
    What proportion of patients with mCRPC who are receiving enzalutamide and 177Lu-PSMA-617 are likely to experience a 90% reduction in their prostate-specific antigen levels from baseline after 20 months?

    mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen.

    The ENZA-p study evaluated the activity and safety of combining enzalutamide with adaptive dosing of 177Lu-PSMA-617 vs enzalutamide alone as a first-line treatment for mCRPC. Outcomes from the prespecified interim analysis after a median of 20 months (data cut-off: 18 May 2023) showed that 78% of patients receiving 177Lu-PSMA-617 had a 90% reduction from their baseline prostate-specific antigen level vs 37% of those receiving enzalutamide alone. 

    Abbreviations

    mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen.

    Reference

    Emmett L, et al. Presented at ESMO Congress 2023, 20–24 October 2023. Madrid, Spain. Abstr LBA84.

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    This Activity Is Funded By:

    An independent medical education grant from Advanced Accelerator Applications. This activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 27 November 2023. Date credits expire: 27 November 2024.

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