Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial.

Importance: Hypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT. Objective: To evaluate whether a hyaluronic acid rectal spacer could (1) improve rectal dosimetry and (2) affect acute grade 2 or higher GI toxic effects for hypofractionated RT. Design, Setting, and Participants: This randomized clinical trial was conducted from March 2020 to June 2021 among 12 centers within the US, Australia, and Spain, with a 6-month follow-up. Adult patients with biopsy-proven, T1 to T2 prostate cancer with a Gleason score 7 or less and prostate-specific antigen level of 20 ng/mL or less (to convert to µg/L, multiply by 1) were blinded to the treatment arms. Of the 260 consented patients, 201 patients (77.3%) were randomized (2:1) to the presence or absence of the spacer. Patients were stratified by intended 4-month androgen deprivation therapy use and erectile quality. Main Outcomes and Measures: For the primary outcome, we hypothesized that more than 70% of patients in the spacer group would achieve a 25% or greater reduction in the rectal volume receiving 54 Gy (V54). For the secondary outcome, we hypothesized that the spacer group would have noninferior acute (within 3 months) grade 2 or higher GI toxic effects compared with the control group, with a margin of 10%. Results: Of the 201 randomized patients, 8 (4.0%) were Asian, 26 (12.9%) Black, 42 (20.9%) Hispanic or Latino, and 153 (76.1%) White; the mean (SD) age for the spacer group was 68.6 (7.2) years and 68.4 (7.3) years for the control group. For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P < .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, -10.9%; 95% 1-sided upper confidence limit, -3.5; P = .01). Conclusions and Relevance: The trial results suggest that rectal spacing with hyaluronic acid improved rectal dosimetry and reduced acute grade 2 or higher GI toxic effects. Rectal spacing should potentially be considered for minimizing the risk of acute grade 2 or higher toxic effects for hypofractionated RT. Trial Registration: ClinicalTrials.gov Identifier: NCT04189913.

Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezum system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: This report evaluates clinical experience with the Rezum system after US Food and Drug Administration clearance in consecutive cases accrued by multiple community urologists for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Treatment techniques for transurethral convective radiofrequency water-vapor thermal therapy and outcomes with up to 12 months' follow-up are presented. MATERIALS AND METHODS: A total of 131 patients with moderate-severe LUTS were included in a retrospective analysis of BPH procedures with the Rezum system. Pre- and postprocedure assessments included International Prostate Symptom Score (IPSS), quality of life, peak urinary flow rate, voided volume, and postvoid residual urine volume. Urologists used their own discretion for patient selection, with variable prostate sizes, LUTS severity, urinary retention, or presence of an obstructing median lobe. Safety signals and surgical retreatment rates were monitored prospectively. RESULTS: Men aged 47-96 years with prostates 13-183 cm3 showed significant improvement in IPSS, quality of life, and postvoid residual volume durable through 12 months after thermal therapy. Patients with either moderate (IPSS 8-19) or severe (IPSS 20-35) symptoms achieved significantly improved scores. Postprocedure adverse events normally anticipated and related to endoscopic instrumentation were transient and mild-moderate in nature. No de novo erectile or ejaculatory dysfunction was reported. CONCLUSION: This study corroborates prior published pilot and randomized controlled trial results indicating significant relief of urinary symptoms and reproducibility of responses to thermal therapy. Convective radiofrequency thermal therapy with the Rezum system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.

Prostate cancer survivors' beliefs about screening and treatment decision-making experiences in an era of controversy.

OBJECTIVE: Controversy about the costs and benefits of screening and treatment of prostate cancer (PCa) has recently intensified. However, the impact of the debate on PCa patients has not been systematically studied. METHODS: We assessed knowledge of, and attitudes toward, the U.S. Preventive Services Task Force's (USPSTF) May 2012 recommendation against PSA-based screening among men diagnosed with clinically localized PCa, and tested whether exposure to the recommendation and associated controversy about overtreatment of PCa predicted treatment decisional conflict, affected treatment choice, or increased regret about PSA testing. RESULTS: Accurate knowledge of the USPSTF recommendation was uncommon (19.1%). Attitudes toward the recommendation were negative, and the vast majority (86.5%) remained highly supportive of annual PSA testing in men ≥50. Although exposure to the recommendation and controversy about treatment was associated with lower enthusiasm for screening and treatment, it was not associated with treatment decisions, or greater decisional-conflict, or regret. CONCLUSIONS: Findings may alleviate concern that exposure to PSA-based screening and overtreatment controversies has adversely affected recent cohorts of PCa patients. However, patients remain highly supportive of PSA-based screening. As survivor anecdotes often influence people's medical decisions, it is important to appreciate the scale of opposition to the new recommendation.