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Speaker: Dr. Priyamvada Maitre, India
Important Takeaways
1. Infrastructure, Training, and Safety Are Key: Successful implementation of PSMA theranostic programs requires specialised infrastructure, accredited personnel, and adherence to safety regulations.
2. Global and Regional Guidelines Shape Practice: Countries follow varying standards—such as those from IAEA, SNMMI, and regional organisations—detailing treatment frequencies, staff training, and facility requirements.
3. Logistics for Isotopes Can Drive Costs: Isotope availability and procurement, such as Lutetium-177 or Gallium-68, significantly affect operational costs.
4. Theranostic Workflow Involves a Multidisciplinary Team: Patient management includes input from nuclear physicians, medical physicists, technologists, and specialised nurses.
5. Flexible Implementation Based on Local Constraints: Smaller centres may rely on isotopes like Fluoride-18 with longer half-lives, while larger centres benefit from in-house production of short-lived isotopes.
Key Highlights
Barriers to Implementation:
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Infrastructure: Availability of specialised theranostic centres is crucial.
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Training: Accredited staff, including nuclear physicians and radiation safety officers, are essential for safe program delivery.
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Regulatory Variations: Safety requirements differ across countries, necessitating adherence to local rules.
Global and Regional Guidelines:
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IAEA Standards: Centers should perform at least 100 treatments annually, with a portion focused on PSMA-based therapies.
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US Guidelines: SNMMI suggests 40+ treatments per year for larger centres, including at least 10 PSMA-based therapies.
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Training Requirements: Europe mandates 4-5 years of nuclear medicine training with hands-on experience, while US programs range from 4 months to 2.5 years.
Setting Up a Theranostic Center:
The centre requires a well-defined infrastructure and multidisciplinary team for safe operation, with licensing by national regulatory bodies. The team should include a physician, medical physicist, radiation safety officer, nuclear technologists, and trained nurses. Centres need facilities for radiation monitoring, waste disposal, and emergency procedures. Standard operating procedures (SOPs) should govern all phases—from tracer procurement and storage to post-treatment patient monitoring and waste disposal.
Radiopharmaceuticals and Usage:
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Gallium-68: This is cost-effective for high-volume centres but has a short half-life (68 minutes), which limits transport viability and requires on-site production.
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Fluorine-18: With a longer half-life (110 minutes), Fluorine-18 tracers are ideal for smaller centres as they can be centrally produced and widely distributed.
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Lutetium-177: A beta-emitter with a short range that requires minimal shielding, Lutetium-177 offers combined therapeutic and imaging capabilities.
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Actinium-225: An alpha-emitter with high ionisation and low tissue penetration, Actinium-225 requires less shielding, providing a safer alternative in many clinical contexts.
Multidisciplinary Team's Role in Patient Care:
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The RLT (Radioligand Therapy) team typically comprises multidisciplinary experts, including nuclear medicine physicians, oncologists, radiologists, medical physicists, dosimetrists, and specialised nurses.
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These professionals collaborate to evaluate the patient's history, diagnosis, and staging, using nuclear imaging insights to design personalised treatment plans.
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They also monitor radiation effects and ensure safe and effective therapy delivery.
Operational Protocols for PSMA Therapy:
In practice, PSMA radioligand therapies are typically administered as outpatient procedures. After intravenous administration of Lutetium-177, patients undergo a follow-up scan four to six hours post-injection to confirm uptake. Bloodwork and PSMA PET scans are repeated after every two treatment cycles to evaluate response, side effects, and to plan subsequent cycles.
Personalised Dosimetry and Ongoing Patient Monitoring:
PSMA therapy allows for personalised dosimetry to improve efficacy and minimise toxicity. After each cycle, dosimetry is reassessed to adjust subsequent doses. This iterative approach supports the growing trend of precision medicine, where treatment is tailored to patient response and side effects, potentially enhancing therapeutic outcomes and quality of life.
Conclusion:
Dr. Maitre concluded that establishing a radio theranostic programme is complex but achievable with the right infrastructure, training, and adherence to guidelines. A well-coordinated team is essential to ensure safe, patient-centred care. As new radioligands emerge, programmes must also focus on continual education, patient outreach, and research integration to stay at the forefront of PSMA-based prostate cancer management.
Société Internationale d'Urologie Congress, 23-26 October 2024, New Delhi, India.
