Renal & Urology NewsNeoadjuvant Apalutamide May Up Post-RP Potency Recovery in High-Risk Prostate Cancer

⚠️ Small Study / Early Comparative Evidence

A 73-patient multicenter phase 2 trial randomized men with high-risk localized prostate cancer (Gleason ≥8 or PSA >20 ng/mL) to neoadjuvant apalutamide monotherapy, apalutamide plus abiraterone and ADT, or upfront surgery alone. The hypothesis was that intensified androgen suppression would reduce tumor volume, improve nerve-sparing feasibility, and enhance functional recovery.

Clinical Considerations

• 12-month potency recovery was 50.0% in the apalutamide/abiraterone/ADT arm vs. 17.4% with surgery alone (P=.017); apalutamide monotherapy (37.5%) did not reach significance vs. surgery alone
• Combination therapy produced significantly greater prostate volume reduction on MRI and lower positive surgical margin rates vs. surgery alone but BCR-free survival did not differ across arms at 12 months (75–81%)
• Testosterone recovery occurred in 95.8% of neoadjuvant patients over a median of 3 months, suggesting reversible suppression in this short-course model
• Grade 3+ adverse events occurred in 17 of 73 patients; combination arm toxicities included hypokalemia, neurologic symptoms, and one reversible grade 4 hot flash

Practice Applications

• Recognize potency and margin findings as hypothesis-generating — phase 2, 73 patients, poster presentation, industry-funded; not yet practice-shaping
• Monitor for peer-reviewed publication and phase 3 data before incorporating neoadjuvant apalutamide into high-risk RP counseling
• Consider discussing functional recovery trajectory with high-risk patients as an emerging area of investigation when counseling on neoadjuvant options
• Interpret BCR equivalence across arms as a signal that short-course neoadjuvant therapy did not compromise early oncologic control, though longer follow-up is needed