CRPC: Evidence
TheraP, randomised phase II trial
Population
- Patients with mCRPC treated with prior DOC
- Rising PSA and PSA ≥20 ng/ml
- ECOG PS 0-2
- Imaging: 68Ga-PSMA-11 + FDG PET/CT
- PSMA SUVmax >20 at any site
- No FDG+/PSMA- sites of disease
- Central review
Design
- Stratification factors: disease burden, prior ENZA or ABI, study site
- SPECT/CT at 24h suspend tx if no or minimal uptake (central review)
*Activity schedule not in line with 177Lu-PSMA-617 smPC
Endpoints
Primary endpoint: PSA ≥50% response
Secondary endpoints:
- AEs
- rPFS and PFS
- PSA PFS
- ORR
- PROs
- OS
Primary endpoint: PSA response ≥50% from baseline
- 12-mo PFS rates were 19% and 3% in the 177Lu-PSMA-617 and CABA groups, respectively
- After a median FU of 36 mo, no difference in OS was reported(4)
Key messages:
177Lu-PSMA-617 led to a higher PSA response vs CABA
3. Hofman MS, Emmett L, Sandhu S, et al. Lancet 2021;397:797-804; 4. Hofman MS, Emmett L, Sandhu S, et al. Lancet Oncol 2024;25:99-107