683 Prospective randomized study comparing robotic prostatectomy versus brachytherapy for the treatment of low risk prostate cancer

Giberti, Claudio; Gallo, Fabrizio; Schenone, Maurizio; Cortese, P.; Gastaldi, Emilio; Becco, Davide

doi:10.1016/s1569-9056(16)60685-1

Cited by 14 publications

(18 citation statements)

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“…While it is certainly desirable, evidence for the relative merits and demerits of brachytherapy based on randomized trials is almost non-existent and Giberti's et al recent publication on a small group of 165 randomly assigned men to either surgery or brachytherapy showing similar bPFS is a welcome addition [14]. We are therefore left with large series emanating from excellence centers with 7–12 yr follow-up reports, as the sole basis for the evaluation of the role of brachytherapy in the different prostate cancer risk categories [15–17].…”

Section: Discussionmentioning

confidence: 99%

Long-term biochemical progression-free survival following brachytherapy for prostate cancer: Further insight into the role of short-term androgen deprivation and intermediate risk group subclassification

et al. 2019

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Introduction Brachytherapy is a well-established treatment of localized prostate cancer. Few studies have documented long-term results, specifically biochemical progression-free survival (bPFS) in men with brachytherapy alone, with or without short-term androgen deprivation therapy (ADT), or in combination with external beam radiotherapy (EBRT). Our aim was to analyze long-term bPFS of brachytherapy treated patients. Materials and methods Retrospective analysis of 1457 patients with low and intermediate risk prostate cancer treated with brachytherapy alone (1255) or combined with EBRT (202). Six-months ADT was administrated for all EBRT combined patients and for prostate volume downsizing when >55 cc (328). Failure was by the Phoenix definition. Kaplan-Meier analysis and multivariate Cox regression estimated and compared 10-yr and 15-yr rates of bPFS. Results Median follow-up was 6.1 yr. Ten and 15-yr bPFS rates of the entire cohort were 93.2% and 89.2%, respectively. On multivariate analysis, PSA density (PSAD), ADT and clinical stage were significantly associated with failure. The most powerful independent factor was PSAD with a HR of 3.5 (95% CI, 1.7–7.4) for PSAD above 0.15. No significant difference was found between low and intermediate risks patients regardless of treatment regimen. However, comparison of two intermediate risk groups, Gleason score (GS) 7, PSA<20 ng/ml versus GS≤6 and PSA = 10–20 ng/ml, revealed 10- and 15-yr bPFS rates of 94.2% and 94.2% compared to 88.2% and 79.9%, ( P = 0.022), respectively. ADT improved bPFS rates in low risk patients. The ten and 15-yr bPFS rates were 97.6% and 94.6% compared to 92.3% and 88.2%, ( P = 0.020), respectively. Conclusions Our retrospective large scale study suggests that brachytherapy provides excellent long-term bPFS rates in low and intermediate risk disease. Combination of brachytherapy with EBRT yields favorable outcomes in GS 7 intermediate risk patients and short-term ADT has a positive effect on outcomes in low risk patients. Further prospective studies are warranted to discriminate the role of adding either EBRT and/or ADT to brachytherapy protocols.

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Section: Discussionmentioning

confidence: 99%

Long-term biochemical progression-free survival following brachytherapy for prostate cancer: Further insight into the role of short-term androgen deprivation and intermediate risk group subclassification

et al. 2019

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“…In fact, there is a large amount of evidence that increasing the dose to the prostate is associated with an improvement in biochemical progression‐free survival in PCa . On the basis of accumulating evidence from nonrandomized studies and from one single randomized comparison that included a few patients, permanent seed brachytherapy as monotherapy is equivalent to radical prostatectomy in patients who have low‐risk PCa, with less urinary incontinence and/or erectile dysfunction in the short term . A feasibility study has shown that recruitment to surgery versus brachytherapy is not feasible using 2‐step randomization, illustrating the difficulty of comparing both strategies .…”

Section: Brachytherapy In the Global Oncological Landscapementioning

confidence: 99%

Brachytherapy: An overview for clinicians

Chargari

Deutsch

Blanchard

et al. 2019

CA A Cancer J Clinicians

210

125

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Brachytherapy is a specific form of radiotherapy consisting of the precise placement of radioactive sources directly into or next to the tumor. This technique is indicated for patients affected by various types of cancers. It is an optimal tool for delivering very high doses to the tumor focally while minimizing the probability of normal tissue complications. Physicians from a wide range of specialties may be involved in either the referral to or the placement of brachytherapy. Many patients require brachytherapy as either primary treatment or as part of their oncologic care. On the basis of high-level evidence from randomized controlled trials, brachytherapy is mainly indicated: 1) as standard in combination with chemoradiation in patients with locally advanced cervical cancer; 2) in surgically treated patients with uterine endometrial cancer for decreasing the risk of vaginal vault recurrence; 3) in patients with high-risk prostate cancer to perform dose escalation and improve progression-free survival; and 4) in patients with breast cancer as adjuvant, accelerated partial breast irradiation or to boost the tumor bed. In this review, the authors discuss the clinical relevance of brachytherapy with a focus on indications, levels of evidence, and results in the overall context of radiation use for patients with cancer.

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“…Using only the most recent time point of ‘long‐term follow‐up’ of primary outcomes for a given study population yielded 103 principal studies 14–116 for detailed analysis ( Table S1 , supporting information). There were 99 two‐arm studies (96·1 per cent) and four three‐arm studies (3·9 per cent), with a median of 78 (range 6–1516) patients.…”

Section: Resultsmentioning

confidence: 99%

Research quality and transparency, outcome measurement and evidence for safety and effectiveness in robot-assisted surgery: systematic review

et al. 2020

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Background: Robot-assisted surgery (RAS) has potential panspecialty surgical benefits. High-quality evidence for widespread implementation is lacking. This systematic review aimed to assess the RAS evidence base for the quality of randomized evidence on safety and effectiveness, specialty 'clustering', and outcomes for RAS research. Methods: A systematic review was undertaken according to PRISMA guidelines. All pathologies and procedures utilizing RAS were included. Studies were limited to RCTs, the English language and publication within the last decade. The main outcomes selected for the review design were safety and efficacy, and study purpose. Secondary outcomes were study characteristics, funding and governance. Results: Searches identified 7142 titles, from which 183 RCTs were identified for data extraction. The commonest specialty was urology (35⋅0 per cent). There were just 76 unique study populations, indicating significant overlap of publications; 103 principal studies were assessed further. Only 64⋅1 per cent of studies reported a primary outcome measure, with 29⋅1 per cent matching their registration/protocol. Safety was assessed in 68⋅9 per cent of trials; operative complications were the commonest measure. Forty-eight per cent of trials reported no significant difference in safety between RAS and comparator, and 11 per cent reported RAS to be superior. Efficacy or effectiveness was assessed in 80⋅6 per cent of trials; 43 per cent of trials showed no difference between RAS and comparator, and 24 per cent reported that RAS was superior. Funding was declared in 47⋅6 per cent of trials. Conclusion: The evidence base for RAS is of limited quality and variable transparency in reporting. No patterns of harm to patients were identified. RAS has potential to be beneficial, but requires continued high-quality evaluation.

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683 Prospective randomized study comparing robotic prostatectomy versus brachytherapy for the treatment of low risk prostate cancer

Cited by 14 publications

References 0 publications

Long-term biochemical progression-free survival following brachytherapy for prostate cancer: Further insight into the role of short-term androgen deprivation and intermediate risk group subclassification

Long-term biochemical progression-free survival following brachytherapy for prostate cancer: Further insight into the role of short-term androgen deprivation and intermediate risk group subclassification

Brachytherapy: An overview for clinicians

Research quality and transparency, outcome measurement and evidence for safety and effectiveness in robot-assisted surgery: systematic review

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