# TheraP (ANZUP 1603)

Source: https://onco.cc/trials/therap/  
OnCo record `therap` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT03392428
- Phase: 2
- Setting: mCRPC after docetaxel: 177Lu-PSMA-617 vs cabazitaxel, PSMA PET/FDG PET selected
- Sponsor: ANZUP / Peter MacCallum
- Enrolled: 201
- Result: PSA50 66% vs 37%; OS HR 0.97.
- Outcomes: PSA response ≥50%: 177Lu-PSMA-617 66% vs Cabazitaxel 37%; Overall survival: 177Lu-PSMA-617 19.1 months vs Cabazitaxel 19.6 months, HR 0.97
- Replication: Consistent with VISION on activity; the OS equivalence with cabazitaxel is an important nuance for sequencing.

## Notes

- TheraP is the only randomised comparison of a PSMA radioligand against an active chemotherapy comparator rather than against best supportive care or an androgen receptor pathway inhibitor switch, which makes it the trial to cite when the question is whether the radioligand is better than the alternative rather than better than nothing. Men were selected by both PSMA PET and FDG PET, so its population is more tightly defined than VISION's.

## Sources

- ClinicalTrials.gov NCT03392428: https://clinicaltrials.gov/study/NCT03392428

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PSMA PET](https://onco.cc/technologies/psma-pet/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- drugs: [Cabazitaxel](https://onco.cc/drugs/cabazitaxel/), [Lutetium-177 vipivotide tetraxetan](https://onco.cc/drugs/pluvicto/)
- companies: [ANZUP Cancer Trials Group](https://onco.cc/companies/anzup/)
- institutions: [Peter MacCallum Cancer Centre](https://onco.cc/institutions/peter-mac/)
- terms: [Crossover in trials](https://onco.cc/terms/crossover/), [PSA50 / PSA90 response](https://onco.cc/terms/psa50/), [Quality of life and patient-reported outcomes (QoL, PRO)](https://onco.cc/terms/qol-pro/), [Quality-adjusted survival (QALYs and Q-TWiST)](https://onco.cc/terms/quality-adjusted-survival/), [What follows what in castration-resistant prostate cancer](https://onco.cc/terms/prostate-crpc-sequencing/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)
- trials: [CARD](https://onco.cc/trials/card/), [PSMAfore](https://onco.cc/trials/psmafore/), [VISION](https://onco.cc/trials/vision/)
- people: [Michael Hofman](https://onco.cc/people/hofman-michael/)
- key papers: [[ 177 Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial](https://onco.cc/key-papers/paper-therap-lancet-2021/), [Overall survival with [ 177 Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer (TheraP): secondary outcomes of a randomised, open-label, phase 2 trial](https://onco.cc/key-papers/paper-therap-lancet-oncol-2024-update/)
- ideas: [Total-body PET for personalised radioligand dosing](https://onco.cc/ideas/idea-total-body-pet-dosimetry/)

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