3298 - Updated Results of a Phase I Trial of a Prostatic Urethral Lift Implant with SAbR for Men with Prostate Cancer and Benign Prostatic Hyperplasia
Presenter(s)
R. Kudchadker1, J. Kwon2, N. B. Desai3, R. Hannan2, M. Lee4, R. Mauck5, J. Tse5, K. Gaston5, S. Rezaie2, K. Heney1, B. Hornberger5, D. X. Yang2, R. D. Timmerman2, S. Woldu5, and A. Garant2; 1UT Southwestern Medical Center, Dallas, TX, 2Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, 3University of Texas Southwestern Medical Center, Dallas, TX, 4Department of Health Data Science & Biostatistics, University of Texas Southwestern Medical Center, Dallas, TX, 5Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX
Purpose/Objective(s): In our previously reported work, early outcomes at three months demonstrated the safety of combining the Prostatic Urethral Lift Implant with Stereotactic Ablative Radiotherapy (SAbR) in men with prostate cancer (PCa) who have underlying obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). We seek to provide longitudinal follow-up, focusing on late genitourinary toxicity and symptom control.
Materials/Methods: This updated analysis from a phase I non-blinded single-arm, prospective clinical trial included 15 men with intermediate-risk PCa with concurrent symptomatic BPH with an American Urological Association (AUA) score =17. Individuals with estimated prostate volume > 100 cc, prior prostate surgery, prior androgen deprivation therapy, or PSA > 20 ng/ml were excluded. PUL, rectoprostatic spacer gel, and fiducial markers were implanted during the same procedure under general anesthesia. Subjects underwent SAbR to a dose of 4000 cGy in 5 fractions to the prostate and proximal seminal vesicles. Complications occurring following use of SAbR were assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5 scale. We evaluated physician-rated adverse events and changes in QoL parameters from baseline as measured by the AUA symptom score using univariable statistical tests. Follow-up occurred quarterly after treatment completion.
Results: Among the 15 participants, the distribution of biopsy Gleason scores of 3+4 and 4+3 were 14 (93.3%) and 1 (6.3%). Among 14 patients who had 6-month follow-up data available, there was a statistically significant decrease in mean AUA score from baseline to 6 months post-radiation (22.07 to 13.64; paired t-test p<0.001). At 15 months post-radiation (n=8), the mean AUA score was 14.12 (SD 8.76). Toxicity grades remained low from baseline across subsequent follow-up timepoints, with no statistically significant mean change from baseline to 6-month post-radiation (0.5 to 1.1) among 10 patients had available toxicity data at 6 months post-radiation. There was an absence of related severe adverse events or hospital admissions with a median follow-up of 15 months.
Conclusion: This study provides prospective evidence that PUL followed by SAbR, appears to be a longitudinally safe treatment for PCa patients with underlying BPH, with low complication rates and sustained reduction in LUTS burden up to 15-months post-SAbR.