Genomic analysis and long-term outcomes of a phase 1 clinical trial on cytoreductive radical prostatectomy.

Approximately 7% of patients with newly diagnosed prostate cancer (PCa) in the US will have have metastatic disease. The dogma that there is no role for surgery in this population has been questioned recently. Here we report long-term outcomes of a phase 1 clinical trial on cytoreductive radical prostatectomy.

This is a multicenter phase 1 trial. The major inclusion criterion was biopsy proven N1M0 or NxM1a/b PCa. Primary end point was the Clavien-Dindo-based major complication rate. Secondary outcomes were biochemical progression and overall survival. RNA-seq correlative study was conducted in nine select cases as a pilot study.

Final accrual was 32 patients of which 25 and 7 were cNxM1 and cN1M0, respectively. With the median follow-up of 46 months (interquartile range 31.7 - 52.7 months), 25 out of the 32 patients (75%) were alive at the time of last contact. There were three disparate groups based on the oncologic outcome: favorable, intermediate, and poor. In seven men with favorable response, androgen deprivation therapy was switched to intermittent approach and five remain free of any evidence of disease after more than two years off all systemic therapy with the normalization of serum testosterone. Of these five patients, three had M1 disease. Long-term use of one pad or less per day was 80%. RNA-seq analysis revealed an enriched downregulation of tumor necrosis factor (TNF)-α signature in the favorable group.

Overall long-term oncologic outcome of cytoreductive radical prostatectomy was significantly higher than historical results. Importantly, the combination of surgery with systemic therapy may result in a long durable response in a minority of men who present with metastatic PCa.

Prostate international. 2022 Mar 09 [Epub]

Isaac Yi Kim, Antonina Mitrofanova, Sukanya Panja, Joshua Sterling, Arnav Srivastava, Juliana Kim, Sinae Kim, Eric A Singer, Thomas L Jang, Saum Ghodoussipour, Biren Saraiya, Tina Mayer, Hatem E Sabaawy, Bertram Yuh, Seok Soo Byun, Wun-Jae Kim, Shigeo Horie

Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey and Division of Urology, Rutgers Robert Wood Johnson Medical School, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA., Department of Health Informatics, School of Health Related Professions, Rutgers Biomedical and Health Sciences, Rutgers University, Newark, NJ, USA., Department of Biostatistics, Rutgers School of Public Health, The State University of New Jersey, New Brunswick, NJ, USA., Department of Internal Medicine, Rutgers Robert Wood Johnson Medical School, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA., Division of Medical Oncology, Rutgers Cancer Institute of New Jersey, and Departments of Medicine and Pharmacology, Rutgers Robert Wood Johnson Medical School, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA., Division of Urology and Urologic Oncology, City of Hope National Medical Center, Duarte, CA, USA., Department of Urology, Seoul National University Bundang Hospital, Bundang, Korea., Department of Urology, Chungbuk National University College of Medicine, Cheongju, Korea., Department of Urology, Juntendo University Graduate School of Medicine, Tokyo, Japan.

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