TheraP (ANZUP 1603)
The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.
200 men; PSA50 66% vs 37%; PFS HR 0.63; OS similar (HR 0.97, 2024) with crossover; quality of life better with Lu-PSMA.
- 66 vs 37 out of 100 had their tumour shrink with 177Lu-PSMA-617 compared with Cabazitaxel; 29 more per 100.
- Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 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.
- Median 19.1 vs 19.6 months with 177Lu-PSMA-617 compared with Cabazitaxel; about 0.5 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 3 percent lower chance of the event at any given time (hazard ratio 0.97).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: mCRPC after docetaxel: 177Lu-PSMA-617 vs cabazitaxel, PSMA PET/FDG PET selected. 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.
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.
200 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| PSA response ≥50%primary | 177Lu-PSMA-617 | 99 | 66% | — | <0.0001 | link |
| Cabazitaxel | 101 | 37% | ||||
| Overall survival | 177Lu-PSMA-617 | — | 19.1 months | 0.97 | — | link |
| Cabazitaxel | — | 19.6 months |
Pages like this
not linked directly; found by shared links- TrialproPSMA
Shares Michael Hofman, ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, PSMA PET.
- InstitutionMovember
Shares Michael Hofman, ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, PSMA PET.
- PersonShahneen Sandhu
Shares ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters).
- PersonRahul Aggarwal
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.
- PersonJohannes Czernin
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.
- PersonMichael J. Morris
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.
- InstitutionPostgraduate Institute of Medical Education and Research, Chandigarh
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.
- InstitutionChulabhorn Hospital / Chulabhorn Royal Academy
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.