One-third of men may experience biochemical failure by 8years following radical radiotherapy for localised prostate cancer. Over 90% of men are started on androgen deprivation therapy (ADT) which is non-curative and confers systemic side-effects.
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Focal salvage therapy (FST) limits collateral tissue damage and may improve therapeutic ratios. In order to deliver FST, distant disease must be ruled-out and intra-prostatic disease must be accurately detected, localised and characterised.
FORECAST - Focal RECurrent Assessment and Salvage Treatment - is a study designed to evaluate a novel imaging-based diagnostic and therapeutic complex intervention pathway for men who fail radiotherapy.
Men with biochemical failure following radical prostate radiotherapy, prior to salvage therapy will be recruited. They will undergo whole-body multi-parametric MRI (WB-MRI), choline PET/CT, bone-scan and pelvic-mpMRI and then MRI Transperineal-Targeted biopsies (MRI-TB) and Transperineal Template Prostate Mapping Biopsy (TPM). Those suitable for FST will undergo either high intensity focused ultrasound (HIFU) or cryotherapy.
Primary outcome measures: a) the accuracy of WB-MRI to detect distant metastatic disease; b) accuracy of prostate mpMRI in local detection of radiorecurrent prostate cancer; c) detection accuracy of MRI-TB; and d) rate of urinary incontinence following FST.
Focal salvage therapy may confer lower rates of morbidity whilst retaining disease control. In order to deliver FST, intra- and extra-prostatic disease must be detected early and localised accurately. Novel diagnostic techniques including WB-MRI and MRI-TB may improve the detection of distant and local disease whilst reducing healthcare burdens compared with current imaging and biopsy strategies.
Contemp Clin Trials. 2015 Jul 13. pii: S1551-7144(15)30038-0. doi: 10.1016/j.cct.2015.07.004. [Epub ahead of print]
Kanthabalan A1, Shah T2, Arya M3, Punwani S4, Bomanji J5, Haroon A6, Illing RO7, Latifoltojar A8, Freeman A9, Jameson C9, van der Meulen J10, Charman S10, Emberton M11, Ahmed HU11.
1Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK.
2Division of Surgery and Interventional Science, University College London, UK.
3Department of Urology, UCLH NHS Foundation Trust, UK.
4Department of Radiology, UCLH NHS Foundation Trust, UK; Centre for Medical Imaging, Division of Medicine, University College London, UK.
5Institute of Nuclear Medicine, UCLH NHS Foundation Trust, UK.
6Centre for Medical Imaging and Computing, University College London, UK.
7Department of Radiology, UCLH NHS Foundation Trust, UK.
8Department of Urology, UCLH NHS Foundation Trust, UK; Centre for Medical Imaging, Division of Medicine, University College London, UK.
9Department of Pathology, UCLH NHS Foundation Trust, UK.
10London School of Hygiene and Tropical Medicine, London, UK.
11Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK.