TABLE 2.
AR Tumor Status, 18F-FDHT PET/CT, and Clinical Outcomes
| Participant no. | Lesions (n) | AR status | Archival tissue location | 18F-FDHT SUVmax of hottest lesion at baseline | Change in 18F-FDHT SUVmax from baseline to… | Outcome | |||
|---|---|---|---|---|---|---|---|---|---|
| Week 6 | Week 12 | Best overall response | Week of best overall response | Week 24 response | |||||
| 1* | 3 | Positive | Primary | 4.1 | −43% | −70% | NonCR/nonPD | 12 | CB |
| 2 | 2 | Positive | Metastasis | 3.5 | −37% | −36% | NonCR/nonPD | 12 | CB |
| 3 | 2 | Positive | Metastasis | 1.4 | −20% | −8% | NonCR/nonPD | 12 | No CB |
| 4 | 1 | Not assessed | 3.3 | −20% | Off study† | NonCR/nonPD | 6 | No CB | |
| 5 | 8 | Positive | Metastasis | 4.8 | −14% | −22% | PR | 12 | No CB |
| 6 | 4 | Positive | Metastasis | 4.9 | −36% | −35% | SD | 12 | No CB |
| 7 | 5 | Positive | Primary | 5.9 | −27% | −48% | SD | 12 | No CB |
| 8 | 1 | Negative | Metastasis | 1.5 | +30% | +56% | PD | 12 | No CB |
| 9 | 5 | Not assessed | 5.1 | +10% | −20% | PD | 12 | No CB | |
| 10 | 4 | Negative | Metastasis | 3.2 | −17% | Off study† | PD | 7 | No CB |
| 11 | 5 | Positive | Metastasis | 3.4 | −31% | −27% | PD | 12 | No CB |
*Received 18 mg of GTx-024; all others received 9 mg.
†Baseline and week 6 scan only; patient 4 off study week 6 because of toxicity, patient 10 off study week 7 because of progression.
NonCR/nonPD = incomplete response but no PD for participants with nonmeasurable disease by RECIST 1.1; CR = complete response; PR = partial response; SD = stable disease.