Nuclear Medicine Is Advancing Prostate Cancer Treatment, But Brings Unique Considerations for the Treatment Process

Pharmacy Times® interviewed Akram Hussein, PharmD, MBA, BCNP, administrator, nuclear pharmacy at Ohio State University Wexner Medical Center, on his presentation at the APhA 2023 Annual Meeting & Exposition titled “Fighting Advanced Prostate Cancer: The Nuclear Medicine Patient Process.”

Pharmacy Times: How is the patient treatment process different when treating a patient with a radiopharmaceutical versus other non-nuclear oncology medicines?

Akram Hussein, PharmD, MBA, BCNP: Non-nuclear oncology medicine, like chemotherapy treatments, for example, are managed and handled by the oncology team. Patients are seen by the oncologist who prescribes treatment, and the treatment is reviewed and prepared and dispensed by the specialty pharmacy. The dose is delivered to the treatment suite, and then the dose is administered by a nurse.

When it comes to treating patients with radiopharmaceuticals, the process is a bit different. The radio pharmaceutical must be prescribed by an authorized user, usually a nuclear medicine physician, that can also be a radiation oncologist.

The authorized user physician is a physician that completed training and has completed experience requirements set by a nuclear regulatory commission. The radiopharmaceuticals must be prepared under an authorized nuclear pharmacist or must be under the supervision of an authorized user physician.

If an institution does not have a nuclear pharmacy onsite, the physician would be responsible for overseeing both the preparation and administration of the radiopharmaceutical. Now, if an institution has a nuclear has a nuclear pharmacy, typically this type of treatment involving already pharmaceutical would go through the nuclear pharmacy for other institutions that do not have an in house nuclear pharmacy or do not want or have the ability to prepare the radiopharmaceutical drugs already on site, they would need to partner with a commercial nuclear pharmacy for the preparation of the radiopharmaceuticals. The dose would then be transported from the commercial nuclear pharmacy, typically early in the morning, to the hospital or clinic.

Image Credit: Adobe Stock - Magdalena

The other critical different part is that radiation safety must be involved in the safe handling of radiopharmaceuticals because radiopharmaceuticals emit radiation. So usually that means the radiation safety is involved in making sure the radioactive drugs or radiopharmaceuticals or the handling of any radioactive isotopes are handled appropriately and make sure that they're administered safely. Other jobs that they would need to worry about is managing any contamination that could happen during that administration or the preparation of a radiopharmaceuticals and making sure rooms are cleaned properly and decontaminated if needed.

Pharmacy Times: What is the radiopharmaceutical that was recently approved for treating prostate cancer, and when was it approved by the FDA?

Hussein: Lutetium [Lu] 177 vipivotide tetraxetan [Pluvicto; Novartis] also known as lu 177 PSMA 617, received FDA approval in March last year for the treatment of patients with prostate specific membrane antigen [PSMA] positive metastatic castrate resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxine based chemotherapy.

What is also unique with this treatment is that that you can image the patients with one of the diagnostic PSMA PET radiopharmaceuticals like Gallium 68 PSMA-11 or FAT PSMA prior to treating the patient with Lu 177 PSMA 617. To be able to visualize the tumors, that Lu 177 PSMA treatment will target and deliver a damaging radiation to.

The idea here is that you use the same targeting peptide that was used with the diagnostic radiopharmaceutical, in this case PSMA, and you label that peptide with isotope like Lu 177 that can deliver a damaging ionizing energy to the cancer cell.

The approval of this radiopharmaceutical brought a lot of excitement to the prostate populate cancer population. Now our oncologists have another treatment option to consider for the metastatic castrate resistant prostate cancer patients that are not responding poorly responding or not tolerated tolerating other prostate cancer treatments.

Pharmacy Times: What is the patient preparation process for this radiopharmaceutical?

Hussein: So prior to initiating a therapy, the patient must meet the treatment eligibility criteria, must have a positive prostate specific membrane antigen scan, have adequate organ function, and labs must be above the institutional set limits for political treatment. There isn't much really earlier preparation prior to initiating the therapy. But when we're ready to release the patient, so after each [Lu 177 vipivotide tetraxetan] administration, it is important to follow post treatment precaution instructions given to the patient after each cycle to limit the radiation exposure to others, like staying 3 feet away for a specific period of time, including sleeping separately from others.

Pharmacy Times: Who handles patient preparations, accurate measurements, and patient release information in the treatment process for this radiopharmaceutical, and what is the pharmacist’s role?

Hussein: This treatment is a multidisciplinary approach. The oncology team prepares the patient for the day of the treatment, like submitting insurance checks, labs are ordered, or ordering other necessary imaging. On the day of the treatment, the patient meets with the radiation safety team member and treating physician go over radiation safety precautions and answer any questions about the treatment.

Then the nuclear pharmacy prepares and dispenses the [Lu 177 vipivotide tetraxetan] dose, and the nuclear medicine technologist prepares the patient to receive the [Lu 177 vipivotide tetraxetan] injection, and the authorized user physician, in most cases, the nuclear medicine physician, administers the radiopharmaceutical treatment to the patient and then the patient is released.

So the role of a nuclear pharmacist here is to review the therapy appropriateness, drug preparation and ordering, dispensing, and also serves as a clinical education resource for the clinical team.

Pharmacy Times: What is the treatment site for this radiopharmaceutical?

Hussein: [Lu 177 vipivotide tetraxetan] are typically administered in radiation restricted areas within for example, nuclear medicine or radiation oncology department. The staff of these departments are equipped and completed extensive radiation safety training on how to handle radiation emitting drugs.

Pharmacy Times: Are radiopharmaceuticals common in the treatment of prostate cancer?

Hussein: Yes, to put it simply, the radiopharmaceuticals travel to the tumor and deliver damaging radiation to the tumor, often with lower side effects as compared to chemo drugs. Another common radiotherapy used over the past 10 years for prostate cancer treatment is [radium (Ra) 223 dichloride (Xofigo; Bayer)]. [Ra 223 dichloride] is as prescribed to treat prostate cancer that spread to the bones and has no known visceral metastatic disease. So what's unique about [Lu 177 vipivotide tetraxetan] is it can treat prostate cancer that has spread to other parts of the body, including the bones.

Pharmacy Times: How equipped are pharmacies currently to treat patients effectively and safely with this new radiopharmaceutical approved for a prostate cancer indication?

Hussein: Hospitals or other providers with nuclear pharmacies are generally the most equipped to treat patients effectively and safely with this new radiopharmaceutical. So first and foremost, you need a nuclear pharmacy or a designated drug preparation area that is USP radiopharmaceuticals General Chapter 825 compliant.

There's also some key characteristics you need within your institution to make sure that the process is seamless, because managing this treatment can be incredibly complex, really due to the patient's scheduling, ordering, and logistical challenges that may be encountered. Managing this treatment needs to be a team-based approach to ensure that there is good communication across all various departments involved, like nuclear pharmacy, pharmacy, oncology, nursing, nuclear medicine, radiation safety, and the insurance benefits team.