Table 1.
Decision table based on the diagnostic outcomes of the PEPPER-study cohort
| Ground truth | Diagnosis | Patients (n) | Frequency (%) | SE (%) | ePLND spared (y/n) | Diagnostic scheme | Curative treatment scheme | Health state |
|---|---|---|---|---|---|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CT scenario | ||||||||
| N0 patients | ||||||||
| pN0 | pN0 | 49 | 91% | - | No | GPP + MRI + ePLND | RT/RP | NEOD-N0 |
| pN0 | iN1lim | 5 | 9% | 3.9% | Yes*** | GPP + MRI | RT/RP + Pelvic RT + ADT | NEOD-N0 |
| pN0 | iN1ext | 0 | NA***** | - | Yes** | NA | NA | NA |
| N1Lim patients | ||||||||
| pN1lim | pN0 | 24 | 65% | 7.8% | No* | GPP + MRI + ePLND | RT/RP + Pelvic RT + ADT | NEOD-N1 |
| pN1lim | iN1lim | 12 | 32% | - | Yes | GPP + MRI | RT/RP + Pelvic RT + ADT | NEOD-N1 |
| pN1lim | iN1ext | 1 | 2.7% | 2.7% | Yes** | GPP + MRI | NA | False palliative |
| N1Ext patients | ||||||||
| pN1ext | pN0 | 0 | NA***** | - | No* | NA | NA | NA |
| pN1ext | iN1lim | 1 | 33% | 27.2% | Yes*** | GPP + MRI | RT/RP + Pelvic RT + ADT | Palliative |
| pN1ext | iN1ext | 2 | 67% | - | Yes | GPP + MRI | NA | Palliative |
| M1 patients | ||||||||
| pM1 | iM1 | 8 | 100% | - | Yes**** | GPP + MRI | NA | Palliative |
| Standard of care scenario | ||||||||
| N0 patients | ||||||||
| pN0 | pN0 | 54 | 100% | - | No | GPP + MRI + ePLND | RT/RP | NEOD-N0 |
| N1Lim Patients | ||||||||
| pN1lim | pN1lim | 37 | 100% | - | No | GPP + MRI + ePLND | RT/RP + Pelvic RT + ADT | NEOD-N1 |
| N1Ext patients | ||||||||
| pN1ext | pN1ext | 3 | 100% | - | No | GPP + MRI + ePLND | NA | Palliative |
| M1 Patients | ||||||||
| pM1 | pN0 | 8 | 100% | - | No | GPP + MRI + ePLND | RT/RP | Palliative |
The proportion was used to define treatment costs and utilities. The patients distribution among states was used as cohort for the Markov simulation. ADT Androgen deprivation therapy, ePLND extended pelvic lymph node dissection, GPP = [68Ga]Ga-PSMA-11 PET/CT, MRI magnetic resonance imaging, M1 distant metastasis including extra pelvic lymph node metastasis, bone and/or visceral metastasis, N0 no lymph node metastasis, N1lim limited lymph nodes metastasis defined as less than or equal to four pelvic lymph node metastasis, N1ext extended lymph nodes metastasis defined as more than four pelvic lymph node metastasis, NA not applicable, NEOD no evidence of disease, PET/CT positron emission tomography/computed tomography, PSMA prostate specific membrane antigen, RP radical prostatectomy, RT radiotherapy.
*ePLND would reveal misdiagnosis of the [68Ga]Ga-PSMA-11 PET/CT and therefore assuring correct treatment
**Misdiagnosis by [68Ga]Ga-PSMA-11 PET/CT would result in false positive palliative state and thus causing lower treatment effects
***Misdiagnosis by [68Ga]Ga-PSMA-11 PET/CT would result higher treatment costs for pelvic radiotherapy and ADT but equal outcomes regarding after treatment effects
****ePLND would not recognize the M1 state resulting in higher treatment costs and lower treatment utilities for these patients in the standard of care. However after treatment effects would be equal
*****It was assumed to be impossible to overestimate more than 4 lymph nodes metastases in N0 patients and vice versa