Neoadjuvant docetaxel, radiotherapy feasible in high-risk prostate cancer

Neoadjuvant radiation therapy and docetaxel prior to prostatectomy in men with localized high-risk prostate cancer has a modest toxicity profile and results in reasonable long-term outcomes, but pathologic complete response (pCR) is not achieved, results of a phase I/II trial have shown.

Researchers assessed the tolerability and efficacy of neoadjuvant radiotherapy and docetaxel before prostatectomy in 25 men with high-risk prostate cancer. The treatment regimen consisted of 45 Gy radiotherapy in 25 fractions to the prostate and seminal vesicles over 5 weeks, along with weekly dose-escalated docetaxel up to 30 mg/m², followed by prostatectomy and bilateral lymph node dissection.

The rate of pCR was the primary endpoint, while adverse events (AEs), symptom and quality of life measures, and prostate-specific antigen metrics were secondary.

All 25 men completed the treatment, but they did not achieve the primary endpoint. The most common grade 3 or higher AE was lymphopenia, with no grade 3 or higher genitourinary or gastrointestinal toxicities observed.

Over a median follow-up of 11.6 years, the biochemical recurrence-free survival at 10 years was 60 percent, while the distant metastasis-free survival was 80 percent. The 10-year prostate cancer-specific survival and overall survival were 84 percent and 60 percent, respectively.

“Further studies are needed to optimize endpoints and assess the efficacy of neoadjuvant treatments compared with standard approaches in high-risk prostate cancer patients,” the researchers said.