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. 2016 Sep;19(3):311-6.
doi: 10.1038/pcan.2016.23. Epub 2016 Jul 19.

PSA nadir as a predictive factor for biochemical disease-free survival and overall survival following whole-gland salvage HIFU following radiotherapy failure

T T Shah  1   2 , M Peters  3 , A Kanthabalan  1   4 , N McCartan  1   4 , Y Fatola  1   4 , J van der Voort van Zyp  3 , M van Vulpen  3 , A Freeman  5 , C M Moore  1   4 , M Arya  4 , M Emberton  1   4   6 , H U Ahmed  1   4
Affiliations

PSA nadir as a predictive factor for biochemical disease-free survival and overall survival following whole-gland salvage HIFU following radiotherapy failure

T T Shah et al. Prostate Cancer Prostatic Dis. 2016 Sep.

Abstract

Background: Treatment options for radio-recurrent prostate cancer are either androgen-deprivation therapy or salvage prostatectomy. Whole-gland high-intensity focussed ultrasound (HIFU) might have a role in this setting.

Methods: An independent HIFU registry collated consecutive cases of HIFU. Between 2005 and 2012, we identified 50 men who underwent whole-gland HIFU following histological confirmation of localised disease following prior external beam radiotherapy (2005-2012). No upper threshold was applied for risk category, PSA or Gleason grade either at presentation or at the time of failure. Progression was defined as a composite with biochemical failure (Phoenix criteria (PSA>nadir+2 ng ml(-1))), start of systemic therapies or metastases.

Results: Median age (interquartile range (IQR)), pretreatment PSA (IQR) and Gleason score (range) were 68 years (64-72), 5.9 ng ml(-1) (2.2-11.3) and 7 (6-9), respectively. Median follow-up was 64 months (49-84). In all, 24/50 (48%) avoided androgen-deprivation therapies. Also, a total of 28/50 (56%) achieved a PSA nadir <0.5 ng ml(-1), 15/50 (30%) had a nadir ⩾0.5 ng ml(-1) and 7/50 (14%) did not nadir (PSA non-responders). Actuarial 1, 3 and 5-year progression-free survival (PFS) was 72, 40 and 31%, respectively. Actuarial 1, 3 and 5-year overall survival (OS) was 100, 94 and 87%, respectively. When comparing patients with PSA nadir <0.5 ng ml(-1), nadir ⩾0.5 and non-responders, a statistically significant difference in PFS was seen (P<0.0001). Three-year PFS in each group was 57, 20 and 0%, respectively. Five-year OS was 96, 100 and 38%, respectively. Early in the learning curve, between 2005 and 2007, 3/50 (6%) developed a fistula. Intervention for bladder outlet obstruction was needed in 27/50 (54%). Patient-reported outcome measure questionnaires showed incontinence (any pad-use) as 8/26 (31%).

Conclusions: In our series of high-risk patients, in whom 30-50% may have micro-metastases, disease control rates were promising in PSA responders, however, with significant morbidity. Additionally, post-HIFU PSA nadir appears to be an important predictor for both progression and survival. Further research on focal salvage ablation in order to reduce toxicity while retaining disease control rates is required.

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Conflict of interest statement

H.U. Ahmed would like to acknowledge funding from the Medical Research Council (UK), the Pelican Cancer Foundation Charity, Prostate Cancer UK, St Peters Trust Charity, Prostate Cancer Research Centre the Wellcome Trust, National Institute of Health Research-Health Technology Assessment Programme, and the US National Institute of Health-National Cancer Institute. H.U. Ahmed also receives funding from USHIFU, Trod Medical and Sophiris Biocorp for clinical trials. Mark Emberton has been awarded National Institute of Health Research (NIHR) Senior Investigator status. He receives research support from the UCLH/UCL NIHR Biomedical Research Centre. Mark Emberton receives funding from USHIFU, Trod Medical and Sophiris Biocorp for clinical trials and is a consultant for Steba Biotech and USHIFU. He also receives funding from the Medical Research Council (UK), the Pelican Cancer Foundation Charity, Prostate Cancer UK, St Peters Trust Charity, Prostate Cancer Research Centre the Wellcome Trust, National Institute of Health Research-Health Technology Assessment Programme, and the US National Institute of Health-National Cancer Institute. T.T. Shah would like to acknowledge funding from the St Peters Trust for clinical research and has received funding for conference attendance from Astellis, Ferring, and Galil medical.

Figures

Figure 1
Figure 1
Progression-free survival for the whole cohort of 50 patients.
Figure 2
Figure 2
Overall survival for the whole cohort of 50 patients.
Figure 3
Figure 3
Progression-free survival by nadir status.
Figure 4
Figure 4
Overall survival by nadir status.
See this image and copyright information in PMC

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