ACDC-RP Trial Insights: Neoadjuvant Therapy Design

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"While the ACDC-RP trial adds to the litany of negative trials in this disease space, there are key takeaways from this trial that can inform future clinical trial design."

BUFFALO, NY- October 7, 2024 – A new editorial was published in Oncotarget's Volume 15 on September 30, 2024, entitled, "Lessons from the ACDC-RP trial: Clinical trial design for radical prostatectomy neoadjuvant therapy trials."

As highlighted at the beginning of the editorial, clinical trials of neoadjuvant therapy have struggled to show significant survival benefits for prostate cancer patients undergoing radical prostatectomy. Limitations include the inclusion of lower-risk patients, small sample sizes, short-term follow-up, reliance on pathologic outcomes as primary study endpoints, and the duration or choice of neoadjuvant systemic therapy.

In their editorial, researchers Rashid K. Sayyid and Neil E. Fleshner from the Division of Urologic Oncology at the Princess Margaret Cancer Centre of the University Health Network, in Toronto, Ontario, reviewed recent clinical trials of neoadjuvant therapy before radical prostatectomy. One such trial, the ACDC-RP (NCT02543255), is an open-label, multicenter phase II study that randomized 70 men with clinically localized, high-risk prostate cancer (D'Amico) to receive either chemohormonal therapy with neoadjuvant cabazitaxel (25 mg/m²) plus abiraterone acetate (1,000 mg/day) and leuprolide acetate or abiraterone acetate plus leuprolide acetate.

The results, according to the authors, strongly suggest that maximal androgen blockade with an androgen receptor pathway inhibitor, combined with an LHRH analogue, should serve as the 'backbone' of neoadjuvant therapy trials.

"We await the results of ongoing trials evaluating biomarker-selected approaches in this disease space."

Continue reading: DOI: https://doi.org/10.18632/oncotarget.28648

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