LuTectomy
In men about to have their prostate removed for high-risk cancer, giving one or two doses of the radioactive drug lutetium-PSMA beforehand delivered a meaningful radiation dose straight to the tumour, was well tolerated, and did not make the surgery harder or riskier.
Overview
LuTectomy was a single-centre, single-arm phase 1/2 study at the Peter MacCallum Cancer Centre investigating neoadjuvant 177Lu-PSMA-617 in men with high-risk localised prostate cancer (PSA >20 ng/mL, ISUP grade group 3-5, or ≥cT2c) with high tumour uptake on 68Ga-PSMA-11 PET, scheduled for robotic radical prostatectomy. Cohort A (n=10) received one cycle and cohort B (n=10) received two cycles of 177Lu-PSMA-617 (5 GBq), with surgery six weeks after the last dose. The primary endpoint was tumour radiation absorbed dose, measured by three-timepoint SPECT-CT dosimetry.
Across 20 patients, the treatment delivered a median highest-lesion dose of 35.5 Gy (19.6 Gy to the prostate, with lymph node doses up to a median of 38-48 Gy in relevant patients), and 45% achieved a PSA decline of 50% or more. Toxicity was low grade only (fatigue, nausea, dry mouth, mild thrombocytopenia), with no grade 3-4 events and no Clavien-Dindo grade 3-5 surgical complications; surgeons reported no unexpected intraoperative difficulty. On pathology, 80% of specimens showed a partial histological response, but no patient achieved a complete pathological response.
LuTectomy is one of the first trials to test PSMA radioligand therapy in the neoadjuvant, potentially curative setting rather than in metastatic disease. It establishes feasibility and biological activity but not yet a benefit in metastasis-free or overall survival; larger trials of multi-cycle or combination regimens are the logical next step, and neoadjuvant PSMA radioligand therapy is not currently part of any clinical guideline.
- 177Lu-PSMA-617 (5 GBq), one or two cycles before prostatectomy: 35.5 Gy.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 45 out of 100 people had their tumour shrink with 177Lu-PSMA-617 before prostatectomy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- 0 out of 100 people had no cancer left at surgery with 177Lu-PSMA-617 before prostatectomy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 0 out of 100 people reached this endpoint with 177Lu-PSMA-617 before prostatectomy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Men with high-risk localised prostate cancer and high PSMA uptake, scheduled for radical prostatectomy; neoadjuvant, pre-surgical setting. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PSMA); the result should not be assumed for people whose cancer does not have it.
- Only 20 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
20 enrolled.
median, IQR 19.5-50.1; 19.6 Gy (IQR 11.3-48.4) delivered to the prostate specifically
Source9/20 patients achieved a >50% PSA decline
0 of 20 patients; 80% showed a partial histological response (fibrosis, reduced tumour cell density)
none observed; surgery was feasible and safe in all patients
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Highest tumour radiation absorbed dose after cycle 1primary | 177Lu-PSMA-617 (5 GBq), one or two cycles before prostatectomy | 20 | 35.5 Gy | - | - | link |
| PSA50 response | 177Lu-PSMA-617 before prostatectomy | 20 | 45% | - | - | - |
| Pathological complete response | 177Lu-PSMA-617 before prostatectomy | 20 | 0% | - | - | - |
| Grade 3/4 toxicity and Clavien-Dindo grade 3-5 surgical complications | 177Lu-PSMA-617 before prostatectomy | 20 | 0% | - | - | - |
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