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Effect of Prostate Volume and Minimum Tumor Temperature on Four-Year Quality-of-Life Following Focal Cryoablation Compared with Active Surveillance in Men with Prostate Cancer

Monaco, Ashley; Sommer, Jessica; Akerman, Meredith; Joshi, Parth; Corcoran, Anthony; Katz, Aaron E
BACKGROUND:The purpose of this study is to analyze quality-of-life (QoL) metrics in men treated with focal cryoablation (FC) compared to active surveillance (AS) for localized PCa over a four-year follow-up period. We further investigated the effect of prostate size and minimum tumor temperature on QoL outcomes. METHODS:An Institutional Review Board-approved database was reviewed for patients who underwent FC or AS. QoL questionnaire responses were collected and scores were analyzed for differences between FC and AS, between prostate volume <50 cc and > 50 cc, and "cold" (<-78°C) and "warm" (>-78°C) tumor temperatures. RESULTS:148 AS and 60 FC patients were included. Compared to AS, no significant difference existed in urinary function measured by EPIC (p=0.593) and IPSS (p=0.241), bowel habits (p=0.370), or anxiety (p=0.672) across time post-FC. FC had significantly worse sexual function compared to AS measured by EPIC (p<0.0001) and IIEF (p<0.0001). Patients with prostate volume <50cc did not demonstrate differences between AS and FC in urinary function on EPIC (p=0.459) or IPSS (p=0.628) but FC patients had worse sexual function on EPIC (p<0.001) and IIEF (p<0.001). FC patients with a prostate volume >50cc had better urinary function measured by IPSS (p<0.05) and similar sexual function on EPIC (p=0.162) and IIEF (p=0.771) compared to AS. Urinary function over time measured by EPIC (0.825) and IPSS (p=0.658) was the same between AS, "warm", and "cold" FC groups. AS had significantly better sexual function than the "warm" and "cold" FC groups on EPIC (p<0.001) and IIEF (p<0.05). CONCLUSIONS:No differences were found in anxiety, urinary, or bowel function between AS and FC. Despite differences in sexual function, patients with larger prostates had no difference in sexual function and improved urinary function compared to AS. Future studies with larger cohorts are needed.
PMID: 36106598
ISSN: 1557-900x
CID: 5336312

An Evaluation of Sexual Function in The Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device

Elterman, Dean; Alshak, Mark; Martinez Diaz, Susana; Shore, Neal; Gittleman, Marc; Motola, Jay; Pike, Sheldon; Hermann, Craig; Terens, William; Kohan, Alfred; Gonzalez, Ricardo; Katz, A E; Schiff, Jeffrey; Goldfischer, Evan; Grunberger, Ivan; Tu, Le Mai; Kaminetsky, Jed; Chughtai, Bilal
PURPOSE/OBJECTIVE:To document the effect of the temporarily implanted nitinol device (iTind, Olympus, Shinjuku City, Tokyo, Japan) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. METHODS:Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. RESULTS:We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared to baseline. Men in the iTind arm without erectile dysfunction (ED) at baseline also showed an improvement in total IIEF score of +6.07 ± 21.17 points (p=0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. CONCLUSION/CONCLUSIONS:No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function.
PMID: 36070450
ISSN: 1557-900x
CID: 5337032

Comparative results of focal-cryoablation and stereotactic body radiotherapy in the treatment of unilateral, low-to-intermediate-risk prostate cancer

Monaco, Ashley; Sommer, Jessica; Okpara, Chinyere; Lischalk, Jonathan W; Haas, Jonathan; Corcoran, Anthony; Katz, Aaron
OBJECTIVE:The purpose of this study is to compare oncologic and functional outcomes of men with unilateral, localized PCa treated with stereotactic body radiotherapy (SBRT) versus focal cryoablation (FC). METHODS:Patients from our IRB-approved PCa database who underwent FC or SBRT and were eligible for both treatments were included. Patients with less than 1 year of follow-up or prior PCa treatment were excluded. The primary outcome was treatment failure, defined as salvage treatment or a Gleason group (GG) of ≥ 2 on post-treatment biopsy. Biochemical recurrence (BCR) was evaluated with Phoenix. Functional outcomes were based on EPIC surveys. Complications were categorized with the CTCAE 5.0. Outcomes were compared using descriptive statistics, univariate analyses, and Kaplan-Meier curve for failure-free survival (FFS) and BCR-free survival. P < 0.05 was significant. RESULTS:68 FC and 51 SBRT patients with a median age of 68 years (48-86) and a median follow-up time of 84 (70-101) months were included in this analysis. There was no difference in tumor risk (p = 0.47), GG (p = 0.20), or PSA (p = 0.70) among the two cohorts at baseline. At 7-year follow-up, no difference in FFS was found between the two cohorts (p = 0.70); however, significantly more FC patients had BCR (p < 0.001). At 48 months, no differences existed in urinary or bowel function; however, SBRT patients had significantly worse sexual function (p = 0.032). CONCLUSION/CONCLUSIONS:FC and SBRT are associated with similar oncologic and functional outcomes 7-year post-treatment. These results underscore the utility of FC and SBRT for the management of unilateral low-to-intermediate-risk PCa.
PMID: 35864430
ISSN: 1573-2584
CID: 5279352

Four-year quality-of-life outcomes in low- to intermediate-risk prostate cancer patients following definitive stereotactic body radiotherapy versus management with active surveillance

Monaco, Ashley; Sommer, Jessica; Akerman, Meredith; Lischalk, Jonathan W; Haas, Jonathan; Corcoran, Anthony; Katz, Aaron
OBJECTIVE:To review quality-of-life (QoL) metrics between patients who underwent definitive stereotactic body radiotherapy (SBRT) versus active surveillance (AS) for management of low- to intermediate-risk prostate cancer (PCa). METHODS:A prospectively maintained PCa database was reviewed containing results of patient-reported QoL surveys. Patients with localized disease who chose AS or SBRT and completed at least one survey within four years of treatment were included. Patients who received salvage therapy were excluded. Survey results were compared across time using mixed-effects repeated measures analysis of covariance models that adjusted for factors significant in univariate analysis. A group x time interaction effect was examined to compare rate of change over time between AS and SBRT. P < 0.05 was significant. RESULTS:148 AS and 161 SBRT patients were included. Significantly more SBRT patients had intermediate-risk disease (p < 0.0001). AS had significantly worse sexual function compared to SBRT across time. While not significant, bowel function scores were lower for SBRT patients across time points. SBRT patients had significantly lower anxiety than AS patients at 24 months (p < 0.011) and 36 months (p < 0.010). Urinary function though worse in SBRT patients at 12 months in EPIC, was not significantly different in both groups across time points. CONCLUSION/CONCLUSIONS:SBRT patients have excellent QoL compared to AS with regard to anxiety post treatment. Though SBRT patients initially have worse urinary and bowel function than AS, scores were eventually similar in both cohorts by 48 months. SBRT patients have significantly worse sexual function post treatment. This study may help facilitate counseling in patients choosing PCa treatment.
PMID: 35821267
ISSN: 1433-8726
CID: 5269152

Prostate cancer treatment and the relationship of androgen deprivation therapy to cognitive function

Reiss, A B; Saeedullah, U; Grossfeld, D J; Glass, A D; Pinkhasov, A; Katz, A E
Prostate cancer is the second most common form of cancer in men. For advanced, high risk prostate cancer, androgen deprivation therapy (ADT) is the preferred treatment and can induce remission, but resistance to ADT brings biochemical recurrence and progression of cancer. ADT brings adverse effects such as erectile dysfunction, decreased libido, and diminished physical strength. It is estimated that between 25 and 50% of men on ADT manifest some form of cognitive dysfunction that may be self-reported or reported by a family member. There is concern that impaired cognitive function with ADT is due to loss of testosterone support. Testosterone and its metabolites are known to possess neuroprotective properties. While a direct causal relationship between ADT and cognitive decline in prostate cancer patients has not been established, this review describes the controversy surrounding the possible connection between ADT and neurocognitive deterioration. The cellular and molecular mechanisms believed to underlie the protection of neuronal integrity by androgens are discussed. Results from animal models and human clinical studies are presented. Finally, we call attention to lifestyle modifications that may minimize cognitive issues in prostate cancer patients.
PMID: 34743290
ISSN: 1699-3055
CID: 5217912

Salvage Prostate Stereotactic Body Radiation Therapy After Definitive Cryoablation

Lischalk, Jonathan W; Katz, Aaron E; Blacksburg, Seth R; Mendez, Christopher; Sanchez, Astrid; Repka, Michael C; Witten, Matthew; Taneja, Samir; Lepor, Herbert; Haas, Jonathan A
Purpose/UNASSIGNED:Whole gland cryoablation is a guideline-approved definitive treatment for localized prostate cancer, and is being explored for partial gland ablation. However, there is limited data regarding management of cryoablation failures. Stereotactic body radiation therapy (SBRT) is a well-established method of primary treatment for prostate cancer. Here we review salvage SBRT after cryoablation failures. Methods and Materials/UNASSIGNED:A large database of patients treated with definitive SBRT was interrogated to identify those who underwent primary cryoablation. All patients were determined to have progressive disease based on a rising prostate specific antigen and/or postcryoablation biopsy. All patients were treated with SBRT over 5 treatment fractions using a robotic radiosurgical platform. Baseline cryoablation characteristics and pre- and posttreatment Expanded Prostate Cancer Index Composite questionnaires were analyzed. Acute and late toxicity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Cancer outcomes after salvage SBRT were stratified by disease and treatment characteristics. Results/UNASSIGNED:A total of 51 patients were identified who underwent cryoablation followed by salvage SBRT. The majority (47%) were found to have intermediate-risk disease at the time of SBRT salvage and most commonly were treated with 3500 cGy in 5 fractions to the prostate and seminal vesicles. Only 1 grade 3+ toxicity was identified. Patient-reported quality of life metrics after SBRT salvage followed prior patterns observed in the de novo SBRT setting. With a median follow-up of 40 months, 76% of the cohort demonstrated disease control. Median time to prostate cancer recurrence was 57.5 months, and recurrence was predominantly seen in patients with underlying high-risk disease. Conclusions/UNASSIGNED:This is the largest cohort of patients treated with any radiation therapy salvage after cryoablation and the first institution to report SBRT as a modality of salvage. Salvage SBRT after cryoablation results in low rates of high-grade toxicity, acceptable changes in patient-reported quality of life, and durable rates of long-term oncologic control.
PMID: 35647408
ISSN: 2452-1094
CID: 5232872

Safety of stereotactic body radiation therapy for localized prostate cancer without treatment planning MRI

Amarell, Katherine; Jaysing, Anna; Mendez, Christopher; Haas, Jonathan A; Blacksburg, Seth R; Katz, Aaron E; Sanchez, Astrid; Tong, Angela; Carpenter, Todd; Witten, Matthew; Collins, Sean P; Lischalk, Jonathan W
BACKGROUND:The use of treatment planning prostate MRI for Stereotactic Body Radiation Therapy (SBRT) is largely a standard, yet not all patients can receive MRI for a variety of clinical reasons. Thus, we aim to investigate the safety of patients who received CT alone based SBRT planning for the definitive treatment of localized prostate cancer. METHODS:Our study analyzed 3410 patients with localized prostate cancer who were treated with SBRT at a single academic institution between 2006 and 2020. Acute and late toxicity was evaluated using the Common Terminology Criteria for Adverse Events version 5.0. Expanded Prostate Cancer Index Composite (EPIC) questionnaires evaluated QOL and PSA nadir was evaluated to detect biochemical failures. RESULTS:A total of 162 patients (4.75%) received CT alone for treatment planning. The CT alone group was older relative to the MRI group (69.9 vs 67.2, p < 0.001) and had higher risk and grade disease (p < 0.001). Additionally, the CT group exhibited a trend in larger CTVs (82.56 cc vs 76.90 cc; p = 0.055), lower total radiation doses (p = 0.048), and more frequent pelvic nodal radiation versus the MRI group (p < 0.001). There were only two reported cases of Grade 3 + toxicity within the CT alone group. Quality of life data within the CT alone group revealed declines in urinary and bowel scores at one month with return to baseline at subsequent follow up. Early biochemical failure data at median time of 2.3 years revealed five failures by Phoenix definition. CONCLUSIONS:While clinical differences existed between the MRI and CT alone group, we observed tolerable toxicity profiles in the CT alone cohort, which was further supported by EPIC questionnaire data. The overall clinical outcomes appear comparable in patients unable to receive MRI for their SBRT treatment plan with early clinical follow up.
PMID: 35366926
ISSN: 1748-717x
CID: 5201512

Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: Recommendations of an international Delphi consensus

Tan, Wei Phin; Rastinehad, Ardeshir R; Klotz, Laurence; Carroll, Peter R; Emberton, Mark; Feller, John F; George, Arvin K; Gill, Inderbir S; Gupta, Rajan T; Katz, Aaron E; Lebastchi, Amir H; Marks, Leonard S; Marra, Giancarlo; Pinto, Peter A; Song, Daniel Y; Sidana, Abhinav; Ward, John F; Sanchez-Salas, Rafael; Rosette, Jean de la; Polascik, Thomas J
BACKGROUND:With the advancement of imaging technology, focal therapy (FT) has been gaining acceptance for the treatment of select patients with localized prostate cancer (CaP). We aim to provide details of a formal physician consensus on the utilization of FT for patients with CaP who are discontinuing active surveillance (AS). METHODS:A 3-stage Delphi consensus on CaP and FT was conducted. Consensus was defined as agreement by ≥80% of physicians. An in-person meeting was attended by 17 panelists to formulate the consensus statement. RESULTS:Fifty-six respondents participated in this interdisciplinary consensus study (82% urologist, 16% radiologist, 2% radiation oncology). The participants confirmed that there is a role for FT in men discontinuing AS (48% strongly agree, 39% agree). The benefit of FT over radical therapy for men coming off AS is: less invasive (91%), has a greater likelihood to preserve erectile function (91%), has a greater likelihood to preserve urinary continence (91%), has fewer side effects (86%), and has early recovery post-treatment (80%). Patients will need to undergo mpMRI of the prostate and/or a saturation biopsy to determine if they are potential candidates for FT. Our limitations include respondent's biases and that the participants of this consensus may not represent the larger medical community. CONCLUSIONS:FT can be offered to men coming off AS between the age of 60 to 80 with grade group 2 localized cancer. This consensus from a multidisciplinary, multi-institutional, international expert panel provides a contemporary insight utilizing FT for CaP in select patients who are discontinuing AS.
PMID: 33676851
ISSN: 1873-2496
CID: 5149752

Stereotactic body radiation therapy for the treatment of localized prostate cancer in men with underlying inflammatory bowel disease

Lischalk, Jonathan W; Blacksburg, Seth; Mendez, Christopher; Repka, Michael; Sanchez, Astrid; Carpenter, Todd; Witten, Matthew; Garbus, Jules E; Evans, Andrew; Collins, Sean P; Katz, Aaron; Haas, Jonathan
BACKGROUND:Historically, IBD has been thought to increase the underlying risk of radiation related toxicity in the treatment of prostate cancer. In the modern era, contemporary radiation planning and delivery may mitigate radiation-related toxicity in this theoretically high-risk cohort. This is the first manuscript to report clinical outcomes for men diagnosed with prostate cancer and underlying IBD curatively treated with stereotactic body radiation therapy (SBRT). METHODS:A large institutional database of patients (n = 4245) treated with SBRT for adenocarcinoma of the prostate was interrogated to identify patients who were diagnosed with underlying IBD prior to treatment. All patients were treated with SBRT over five treatment fractions using a robotic radiosurgical platform and fiducial tracking. Baseline IBD characteristics including IBD subtype, pre-SBRT IBD medications, and EPIC bowel questionnaires were reviewed for the IBD cohort. Acute and late toxicity was evaluated using the CTCAE version 5.0. RESULTS:A total of 31 patients were identified who had underlying IBD prior to SBRT for the curative treatment of prostate cancer. The majority (n = 18) were diagnosed with ulcerative colitis and were being treated with local steroid suppositories for IBD. No biochemical relapses were observed in the IBD cohort with early follow up. High-grade acute and late toxicities were rare (n = 1, grade 3 proctitis) with a median time to any GI toxicity of 22 months. Hemorrhoidal flare was the most common low-grade toxicity observed (n = 3). CONCLUSION/CONCLUSIONS:To date, this is one of the largest groups of patients with IBD treated safely and effectively with radiation for prostate cancer and the only review of patients treated with SBRT. Caution is warranted when delivering therapeutic radiation to patients with IBD, however modern radiation techniques appear to have mitigated the risk of GI side effects.
PMID: 34243797
ISSN: 1748-717x
CID: 4965222

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial

Chughtai, Bilal; Elterman, Dean; Shore, Neal; Gittleman, Marc; Motola, Jay; Pike, Sheldon; Hermann, Craig; Terrens, William; Kohan, Alfred; Gonzalez, Ricardo R; Katz, Aaron; Schiff, Jeffery; Goldfischer, Evan; Grunberger, Ivan; Tu, Le Mai; Alshak, Mark N; Kaminetzky, Jed
OBJECTIVE:To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS/METHODS:Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS:A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION/CONCLUSIONS:Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.
PMID: 33373708
ISSN: 1527-9995
CID: 4770992