Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT (original) (raw)
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BMC Urology, 2020
Background Partial ablation of the prostate using high-intensity focussed ultrasound (HIFU-PA) is a treatment option for localised prostate cancer. When local recurrence occurs, salvage robot-assisted radical prostatectomy is a treatment option for selected patients, but there is a paucity of data on the peri-operative safety, functional and oncologic outcomes of sRARP.. The objective of this study was therefore to describe peri-operative safety, functional and early oncologic outcomes following salvage robot-assisted radical prostatectomy (sRARP) for local recurrence after HIFU-PA. Methods Retrospective analysis of a prospective database of 53 consecutive men who underwent sRARP after HIFU-PA from 2012 to 2018. Continence and erectile-function were reported pre-HIFU, pre-sRARP, 3-months post-sRARP and 12-months post-sRARP. Complications, PSMs and need for subsequent ADT/radiotherapy were assessed. Results 45 men were suitable for inclusion and had sufficient data for analyses. Medi...
BJU international, 2018
To describe how clinicians conceptualised equipoise in the PART (Partial prostate Ablation vs Radical prosTatectomy in intermediate-risk unilateral clinically localised prostate cancer) feasibility study and how this affected recruitment. PART included a QuinteT Recruitment Intervention (QRI) to optimise recruitment. Phase I aimed to understand recruitment, and included: scrutinising recruitment data, interviewing the trial management group and recruiters (n = 13), and audio-recording recruitment consultations (n = 64). Data were analysed using qualitative content and thematic analysis methods. In Phase II, strategies to improve recruitment were developed and delivered. Initially many recruiters found it difficult to maintain a position of equipoise and held preconceptions about which treatment was best for particular patients. They did not feel comfortable about approaching all eligible patients, and when the study was discussed, biases were conveyed through the use of terminology,...
European urology, 2016
High-intensity focused ultrasound (HIFU) is a minimally-invasive treatment for nonmetastatic prostate cancer. To report medium-term outcomes in men receiving primary whole-gland HIFU from a national multi-centre registry cohort. Five-hundred and sixty-nine patients at eight hospitals were entered into an academic registry. Whole-gland HIFU (Sonablate 500) for primary nonmetastatic prostate cancer. Redo-HIFU was permitted as part of the intervention. Our primary failure-free survival outcome incorporated no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer-specific mortality. Secondary outcomes included adverse events and genitourinary function. Mean age was 65 yr (47-87 yr). Median prostate-specific antigen was 7.0 ng/ml (interquartile range 4.4-10.2). National Comprehensive Cancer Network low-, intermediate-, and high-risk disease was 161 (28%), 321 (56%), and 81 (14%), respectively....
Journal of Personalized Medicine, 2022
To compare oncological and functional outcomes of high-intensity focused-ultrasound (HIFU) focal therapy (FT) versus laparoscopic radical prostatectomy (LRP) in patients treated for low- or intermediate-risk prostate cancer (PCa), we retrospectively analyzed data of consecutive patients comprising 30 men, who underwent HIFU-FT, and 96 men who underwent LRP, in an academic center. Oncological outcomes were assessed based on the follow-up prostate-specific antigen values. We used the International Index of Erectile Function short form score to assess erectile function (EF). Urinary continence status was defined based on the number of pads used per day. Median follow-up was 12.5 and 19.1 months in the LRP and HIFU-FT groups, respectively. The effects were computed after propensity score matching and expressed as average treatment effect (ATE). Compared to LRP, HIFU-FT was associated with increased risk of treatment failure (ATE 0.103–0.164, depending on definition, p < 0.01) and low...
Health technology assessment (Winchester, England), 2015
For people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others. This study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT. MEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April ...
Oncologic and functional outcome of partial gland ablation with HIFU for localized prostate cancer
The Journal of urology, 2018
We assessed the outcomes of high-intensity focused ultrasound for the primary treatment of localized prostate cancer in a retrospective series. This represents one of the largest published series of intermediate and high-risk patients. A retrospective, multicenter analysis of patients who underwent partial gland ablation (PGA) between January 2013 to September 2017 was performed. Patients with biopsy-proven localized disease and limited multifocality based on MRI, who preferred a minimally invasive outpatient treatment, were treated with the Sonablate 500 system. Oncological and functional outcomes, as well as risk factors for recurrence, were analyzed. A total of 166 procedures were performed in 150 patients. Grade group ≥ 2 was present in 89% cases. Mean follow-up was 24.3 ± 14.4 months. Mean prostatic-specific antigen decreased 65% from 7.9 ± 6.8 ng/ml to a nadir of 2.7 ± 3.1 ng/ml. Confirmatory biopsies were performed in 87 (52%) high-risk for recurrence patients. Clinically sig...