Table 3.
Study type and study design specific parameters of the included clinical prospective trials with PSMA-radioligands for prostate cancer from the ClinicalTrials.gov registry (n = 104).
| Absolute (n) | Relative (%) * | |
|---|---|---|
| Study phase | ||
| Early Phase-I | 7 | 7 |
| Phase-I | 25 | 24 |
| Phase-I/-II | 13 | 13 |
| Phase-II | 35 | 34 |
| Phase-II/-III | 12 | 12 |
| Phase-III | 12 | 12 |
| Primary purpose | ||
| Diagnostic | 75 | 72 |
| Treatment | 24 | 23 |
| Screening | 3 | 3 |
| Basic Science | 1 | 1 |
| Other | 1 | 1 |
| Allocation | ||
| Non-Randomized | 17 | 16 |
| Randomized | 17 | 16 |
| Not specified | 70 | 67 |
| Masking | ||
| None (Open Label) | 99 | 95 |
| Masked | 5 | 5 |
| Single (investigator) | 1 | 1 |
| Single (participant) | 2 | 2 |
| Double or triple | 2 | 2 |
| Intervention model | ||
| Single Group Assignment | 72 | 69 |
| Parallel Assignment | 20 | 19 |
| Sequential Assignment | 6 | 6 |
| Crossover Assignment | 6 | 6 |
* Sum partly ≠ 100 due to rounding. Source: Own table based on the evaluation of the ClinicalTrials.gov dataset [30].