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The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.
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. OnCo 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.
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 |
A second publication from the TheraP trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT03392428 with the most citations, so it is the natural first reading for anyone following the TheraP trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares PSA50 / PSA90 response, CARD, Cabazitaxel, What follows what in castration-resistant prostate cancer.
Shares PSMAfore, VISION, Lutetium-177 vipivotide tetraxetan, PSMA PET.
Shares Michael Hofman, ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, PSMA PET.
Shares PSMAfore, VISION, Lutetium-177 vipivotide tetraxetan, PSMA PET.
Shares ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters).
Shares PSA50 / PSA90 response, CARD, What follows what in castration-resistant prostate cancer, Quality of life and patient-reported outcomes (QoL, PRO).
Shares Total-body PET for personalised radioligand dosing, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters), Metastatic castration-resistant prostate cancer.
Shares [ 177 Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial, PSMAfore, VISION, Lutetium-177 vipivotide tetraxetan.