Last year, the HSE took the decision not to approve reimbursement for lutetium-PSMA-617 (Lu-PSMA-617) for the treatment of progressive prostate-specific membrane (PSMA)-antigen positive metastatic castration-resistant prostate cancer (mCRPC). The decision followed the HSE Drugs Group’s conclusion that the therapy did not represent optimal use of HSE resources. The announcement was criticised by the Irish oncology community.However, a presentation at the 2026 John Fitzpatrick Irish Genitourinary Cancer Conference, held in Dublin in April, showed the organisational complexity involved in delivering this therapy in a real-world setting.
Lu-PSMA-617 was approved for reimbursement in Canada in December 2024, allowing the treatment to be provided at selected cancer centres, including Princess Margaret Hospital in Toronto. Dr Di Maria Jiang, Medical Oncologist at Princess Margaret, said providing the treatment has required considerable financial and human resource investment.
“There is a lot of operational complexity in giving this treatment to a heavily pretreated patient population. There are a lot of resources and admin support that we need to bring this to our patients,” Dr Jiang said.
“There is a lot of work in the background trying to figure out the right patient population. We have to get CT scans, we have to get PSMA PET scans, and a lot of the time when we get PSMA PET scans, and then our radiologist has to determine whether they meet the VISION [trial] criteria. So, from the time that you have a patient with PSA rise and they are potentially eligible for Lu-PSMA, you have to get the CTs, then you have to get the PSMA PET, then you have to do the tumour board meeting, and then you have to order the drug, which takes about a couple of weeks. That process takes time and a lot of resources.”
The approval of Lu-PSMA was based on the open-label, phase 3 VISION trial, which evaluated 177Lu-PSMA-617 in patients with mCRPC previously treated with at least one androgen-receptor–pathway inhibitor (ARPI) and one or two taxane regimens and who had PSMA-positive gallium-68 (68Ga)-labeled PSMA-11 PET CT scans.
Patients were randomly assigned to receive either 177Lu-PSMA-617 (7.4 GBq every six weeks for four to six cycles) plus protocol-permitted standard care or standard care alone. Protocol-permitted standard care excluded chemotherapy, immunotherapy, radium-223 (223Ra), and investigational drugs. Lu-PSMA was associated with prolonged imaging-based progression-free survival and overall survival when added to standard care.
Princess Margaret Hospital treated its first patient with Lu-PSMA in January 2025. As of April 2026, 75 patients had been treated.
“In terms of who we give Lu-PSMA to, the patient selection criteria are really not standardised across institutions but, generally speaking, we first look at their prior therapies. Do they meet the [VISION trial] criteria? They have to have previous ARPI and prior taxane chemotherapy. Sometimes we see patients with bone-only disease on PSMA PET, and we actually still recommend radium-223 in that case,” Dr Jiang explained.
“If we have a patient with BRCA, and they have not had a PARP inhibitor, we’ll usually go for that before they get Lu-PSMA. And then generally speaking, they have to have reasonable blood counts. At our institution, that is usually haemoglobin above 80 and platelets above 75, otherwise it really becomes a problem.”
Patients are required to comply with radiation safety protocols as they are radioactive following treatment and, therefore, must avoid public transport etc. This can become an issue if patients have to be admitted to hospital.
The Princess Margaret Lu-PSMA experience has uncovered important differences between the clinical trial
and the real-world setting.
“As expected, compared to the VISION trial, in the real-world setting, we are seeing patients who have potentially more aggressive disease, with more de novo metastasis, more liver metastasis. We see patients with higher baseline PSA coming in. We see patients with more anaemia.
We see a lot more patients who are just post-docetaxel because patients do not usually want to go through another line
of chemotherapy if Lu-PSMA is available,” Dr Jiang said.
“In terms of our response rate so far, PSA50 response rate is 38 per cent compared to 46 per cent in VISION. It is a little bit less, but otherwise, in terms of tolerability, the real-world experience has actually been quite similar. We do see a little bit more kidney dysfunction, but so far, there hasn’t been any treatment discontinuation due to adverse events. All of our patients have stopped treatment due to progressive disease.”
“Overall, it is a bit of a steep learning curve to bring this drug into clinical practice but I think, with multidisciplinary effort and experience, it can be done,” Dr Jiang concluded.
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