The news at a glance
- Lutetium-PSMA is a radioactive drug that sticks to prostate cancer cells and delivers radiation straight to them [2].
- Until now it was only used at later stages of the disease [2, 3]; this study tested it in prostate cancer that had spread but still responded to hormone therapy [1].
- In more than a thousand patients, adding this drug to hormone therapy made the disease getting worse, or death, about a quarter less likely [1].
- This use was approved in the US in July 2026; it is not yet known whether it also helps patients live longer [1].
- Overall survival: how long patients lived.
- Progression-free survival: how long the disease did not get worse.
- Disease-free or event-free survival: how long the disease did not come back after treatment.
- Median: the number that half of patients were above and half below; for example, "a median of 10 months" means that in half of patients the disease stayed under control for at least 10 months.
- Phase 3: a large, careful study comparing a new drug with the usual treatment; the basis of most approvals.
Talk to your doctor about what this result means for you.
What does this finding mean for patients?
If your prostate cancer has spread to other parts of the body but still responds to hormone therapy, this targeted radioactive treatment may soon be an option alongside hormone therapy [1]. This treatment needs a PSMA scan to show whether the tumour has this protein. It is not yet known whether it helps people live longer; talk to your doctor before making any decision.
What was reported?
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Today's standard treatment for metastatic hormone-sensitive prostate cancer is androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) [1]. 177Lu-PSMA-617 had previously improved overall survival in the VISION trial in castration-resistant patients who had received taxane chemotherapy (median 15.3 vs 11.3 months) [2], and in PSMAfore it had improved progression-free survival in patients before chemotherapy [3].
The phase 3 PSMAddition trial, at 169 centres in 20 countries, randomised 1,144 patients with metastatic hormone-sensitive prostate cancer and at least one PSMA-positive metastatic lesion on PET to 177Lu-PSMA-617 plus ADT + ARPI, or ADT + ARPI alone [1]. Half of the patients had metastases at diagnosis and 68% had high-volume disease [1].
At the second interim analysis, radiographic progression or death occurred in 24% of the lutetium group and 30% of the control group; the hazard ratio was 0.72 and the primary endpoint was met. Median progression-free survival has not yet been reached in either group [1].
If your prostate cancer has spread to the bones or other organs but still responds to hormone therapy, this study shows that adding targeted lutetium-PSMA radioactive treatment (up to 6 injections into a vein, one every 6 weeks) can delay the disease getting worse [1]. This treatment needs a PSMA PET scan to show whether the tumour is PSMA-positive [1]. The most common side effect was mild dry mouth, and low blood counts and stomach and bowel problems were also seen more often [1]. It is not yet known whether this treatment helps people live longer; talk with your doctors (your oncologist and a nuclear medicine specialist) about its benefits and drawbacks.
Trial details and regimen (for physicians)
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- Patients were selected with centrally read [68Ga]Ga-PSMA-11 PET; control patients could cross over to lutetium after confirmed progression, which will complicate the future interpretation of overall survival [1].
- Serious adverse events 32% vs 29%; 3% were serious adverse events related to lutetium [1].
- A systematic review summarises the evidence for lutetium-PSMA in hormone-sensitive disease (including LUNAR, UpFrontPSMA and the PSMAddition interim analysis) and points to the small sample sizes and short follow-up of most studies [4].
PSMAddition regimen (FDA label)
177Lu-PSMA-617 + androgen receptor pathway inhibitor
PSMA-positive metastatic prostate cancer, androgen pathway modulation-naive or -sensitive (mAPMN/S); selection by approved PSMA PETEach drug’s schedule in the table
PSMA-positive metastatic prostate cancer, androgen pathway modulation-naive or -sensitive (mAPMN/S); selection by approved PSMA PET
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Lutetium Lu 177 vipivotide tetraxetan | 7.4 GBq (200 mCi) | IV (slow push over 1 to 10 minutes or gravity/pump infusion) through a dedicated catheter | Every 6 weeks |
| ARPI (with ADT) | As per that drug's label | Oral | Daily |
Flush the catheter before the injection with at least 10 mL of 0.9% sodium chloride. Only dose-reduction level: 20%, to 5.9 GBq (160 mCi); do not re-escalate; if a second reduction or a delay of more than 4 weeks is needed: discontinue. Grade 2 bone marrow suppression: withhold until grade 1; grade 3 or higher: withhold and reduce the dose; recurrence after reduction: discontinue. Renal toxicity (grade 2 creatinine increase or CLcr below 30): withhold until improvement; creatinine increase of 40% or more and CLcr decrease of more than 40%: withhold and reduce the dose; grade 3 or higher: discontinue. Grade 3 dry mouth or grade 3 or higher gastrointestinal toxicity refractory to treatment: withhold and reduce the dose. Monitor CBC and creatinine/CLcr before and during treatment; good hydration and frequent voiding before and after the injection; follow radiation protection principles; the partner should avoid pregnancy until 14 weeks after the last dose. In PSMAddition, the ADT + ARPI was chosen by the physician [5, 1].
Evidence: PSMAddition (2026)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Limitations and next steps
- In the US, this treatment has been approved, together with the newer hormone tablets, for prostate cancer that has spread but still responds to hormone therapy.
- The results are still early, and it is not yet known whether it helps patients live longer [1].
- Severe side effects were more common with it, and it is only given in centres equipped for nuclear medicine [1].
- Approval: on 31 July 2026 the FDA approved 177Lu-PSMA-617 (Pluvicto) with an ARPI for adults with PSMA-positive metastatic hormone-sensitive prostate cancer (newly termed mAPMN/S) (FDA announcement).
- The results are from the second interim analysis and the study was open-label; overall survival data have not yet been published [1].
- Grade 3 or higher adverse events were more common with lutetium, and the treatment needs a well-equipped nuclear medicine centre [1].
The main study and earlier studies
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Key studies
3 items[177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial
Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial
References
5 referencesShow all references, 4 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2
- 3177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial
- 4Lutetium-177–PSMA radioligand therapy in metastatic hormone-sensitive prostate cancer: A systematic review of efficacy, safety, and combination strategies
- 5PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use: Prescribing Information
This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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