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Reduced Length of ADT and ARTA with XRT in High-Risk Prostate Cancer: A Randomised Controlled Trial
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DOI：10.1016/j.clon.2026.104280.png)
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Abstract
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1. This is a phase II randomised non-inferiority trial evaluating de-escalation of androgen deprivation therapy (ADT) duration in high-risk non-metastatic prostate cancer. 2. The trial compares short intensified androgen suppression (9 months ADT + 6 months ARTA) against the standard 24 months of ADT. 3. All participants undergo PSMA-PET/CT staging and hypofractionated pelvic radiotherapy, reflecting contemporary clinical standards. 4. Both moderate hypofractionation (62-68Gy in 20-25 fractions) and extreme hypofractionation/SBRT (35-36.25Gy in 5 fractions) are permitted per treating oncologist's discretion. 5. The primary endpoint is 5-year disease-free survival, with a pre-specified non-inferiority margin of 10% absolute difference. 6. A total of 206 participants will be enrolled across multiple centres, with stratified randomisation by fractionation schedule and modified Charlson Comorbidity Index. 7. The trial addresses the significant systemic morbidity of prolonged ADT, including cardiovascular toxicity, osteoporosis, metabolic dysfunction, and cognitive decline. 8. Testosterone recovery kinetics are a key secondary endpoint, with recovery defined as serum testosterone exceeding 150 ng/dL. 9. Patient-reported outcomes are systematically assessed using PRO-CTCAE at 6, 12, 24, 36, 48, and 60 months post-randomisation. 10. Results are expected to inform risk-adapted, personalised systemic therapy strategies for PSMA-staged high-risk prostate cancer in the modern radiotherapy era.
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