Table 1 Eligibility criteria
Inclusion criteria | Exclusion criteria |
|---|---|
1. Adult males > 18years of age | 1. Participants who have already commenced ADT or inability to receive ADT. |
2. Participants must have intermediate risk, localised adenocarcinoma of the prostate according to NCCN risk Favourable intermediate risk (FIR): • 1 intermediate risk factor (IRF) • Grade Group 1 or 2 (Gleason Score ≤ 6 or Gleason Score 7 {3 + 4}) • < 50% biopsy cores positive (e.g., < 6 of 12 cores) Unfavourable intermediate risk (UIR) • 2 or 3 IRFs • Grade Group 3 (Gleason Score 7) • ≥ 50% biopsy cores positive (e.g., ≥ 6 of 12 cores) IRFs: • Clinical stage cT2b-cT2c • Grade Group 2 or 3 (Gleason Score 3 + 4 = 7 or 4 + 3 = 7) • PSA 10-20ng/mL | 2. Participants with insufficient tissue and/or histopathology issues which may arise pertaining to the generation of an accurate ArteraAI Prostate Test result. |
3. Participants with histological or cytological evidence of neuroendocrine or small cell differentiation. | |
4. Prostate adenocarcinoma that cannot be International Society of Urological Pathologists (ISUP) graded. | |
5. High risk clinical features (PSA > 20, Grade Group 4–5, Stage T3-4). Node positive or presence of distant metastases (cN1 or cM1). | |
3. Estimated life expectancy > 10 years | |
4. Participants must be planned to undergo curative-intent radiotherapy for prostate cancer | |
5. Willing and able to provide written informed consent |