Clinical features of “anaplastic” prostate carcinomas (eligibility criteria)
| Castrate-resistanta prostate carcinoma with at least 1 of the following: | n (%) |
|---|---|
| C1. Histologic evidence of small-cell prostate carcinoma (pure or mixed). | 29 (25.4) |
| C2. Exclusively visceral metastases. | 19 (16.7) |
| C3. Radiographically predominant lytic bone metastases by plain x-ray or CT scan. | 16 (14.0) |
| C4. Bulky (≥5 cm) lymphadenopathy or bulky (≥5 cm) high-grade (Gleason ≥ 8) tumor mass in prostate/pelvis. | 49 (43.0) |
| C5. Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases. | 26 (22.8) |
| C6. Presence of neuroendocrine markers on histology (positive staining of chromogranin A or synaptophysin) or in serum (abnormal high serum levels for chromogranin A or GRP) at initial diagnosis or at progression. Plus any of the following in the absence of other causes: A. elevated serum LDH (≥2 × IULN); B. malignant hypercalcemia; C. elevated serum CEA (≥2 × IULN). | 21 (18.4) |
| C7. Short interval (≤6 months) to androgen-independent progression following the initiation of hormonal therapy with or without the presence of neuroendocrine markers. | 52 (45.6) |
Abbreviation: GRP, gastrin-releasing peptide.
↵aPatients with small-cell prostate carcinoma on histologic evaluation were not required to have castrate-resistant disease.