TheraP (ANZUP 1603)
The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.
Overview
TheraP, ANZUP trial 1603, NCT03392428, sponsored by ANZUP and Peter MacCallum and reported in 2021, was the randomised phase 2 that first pitted a radioligand against chemotherapy, comparing 177Lu-PSMA-617 with cabazitaxel in metastatic castration-resistant prostate cancer after docetaxel, with patients selected by PSMA and FDG PET. It randomised 200 men, met its primary endpoint with a PSA response of at least fifty percent in 66 percent of men against 37 percent, delayed progression and gave better quality of life with fewer side effects, but overall survival was similar in the 2024 analysis after crossover. Nuclide links it to radioligand therapy, PSMA PET, lutetium-177 vipivotide tetraxetan, cabazitaxel, Michael Hofman and the PSA50 term, and it is consistent with VISION on activity. The survival equivalence with cabazitaxel is the nuance that matters for sequencing, which remains open.
- 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.
201 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 |
For men whose prostate cancer has grown after chemotherapy, a PSMA-targeted radioactive treatment worked at least as well as, and was gentler than, the chemotherapy drug it replaced - provided a PET scan first confirms the cancer takes up the PSMA tracer.
In a small early trial, most heavily pre-treated men with advanced prostate cancer responded to the PSMA-targeted radioactive drug, with manageable side effects, supporting the case for testing it in larger randomised trials.
Similar pages
not linked directly; found by shared links- PersonShahneen Sandhu
Shares Adding a checkpoint inhibitor to PSMA radioligand therapy, ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer.
- TrialVISION
Shares Crossover in trials, Adding a checkpoint inhibitor to PSMA radioligand therapy, LuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer, TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer.
- PersonLouise Emmett
Shares TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer, Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters).
- TrialproPSMA
Shares ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, Michael Hofman, PSMA PET.
- PersonRodney J. Hicks
Shares Amir Iravani, Peter MacCallum Cancer Centre, Lutetium-177 vipivotide tetraxetan, Lutetium-177.
- PersonDeclan G. Murphy
Shares ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, PSMA PET, Prostate cancer.
- PersonMichael J. Morris
Shares TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer, Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters).
- PersonRahul Aggarwal
Shares Lutetium-177 vipivotide tetraxetan, PSMA PET, Radioligand therapy (beta emitters), Prostate cancer.