ArticlesFocal therapy for localised unifocal and multifocal prostate cancer: a prospective development study
Introduction
The management of localised prostate cancer remains controversial because the systematic over-diagnosis that accompanies the current diagnostic pathway results in over-treatment.1 At present, radical whole-gland surgery or radiotherapy can result in substantial side-effects that are a consequence of damage to surrounding structures. These include urinary incontinence (5–20%), erectile dysfunction (30–70%), and bowel toxicity (5–10%).2, 3 Technological refinements do not seem to have reduced the burden of harm.4, 5
Apart from active surveillance for low-risk disease, few strategies are available to address the burden of treatment-related side-effects in other risk categories. One strategy that has shown promise relates to managing prostate cancer in the same manner as most other solid organ malignancies—by focusing the therapy to the cancer lesion, injury to the bladder, rectum, and neurovascular bundles could be reduced.6, 7
We have previously assessed hemi-ablation of patients with localised unilateral prostate cancer,8 which included treatment of the entire half of the prostate associated with cancer. Regardless of the grade, volume, or location of cancer that affected half of the prostate, the entire side was ablated. This strategy is the most straightforward to undertake, standardise, and train others to do, but is limited because only one in five men have true unilateral disease on template biopsies. Furthermore, hemi-ablation might represent overtreatment since a low-volume, low-grade lesion would be treated in the same manner as a high-volume, high-grade cancer. In this study, we postulated that selective focal ablation of unifocal and multifocal cancer lesions with a margin of normal tissue could reduce genitourinary and rectal side-effects for men with localised prostate cancer.
Section snippets
Study design and patients
We undertook a two-centre, prospective development study, as defined by the IDEAL (Idea, Development, Exploration, Assessment, and Long-term) guidelines for assessing innovation in surgery.9 Men could enter into the study if they had localised prostate cancer on multiparametric MRI and transperineal template-prostate-mapping biopsies.10
We included men with low-risk to high-risk disease (prostate-specific antigen [PSA] ≤15 ng/mL, Gleason score ≤4+3, stage ≤T2), aged 45–80 years with a life
Results
42 men were recruited between June 27, 2007, and June 30, 2010. One man had an unrelated death 3 months after focal therapy. He had baseline retroperitoneal fibrosis, hypertension, and a single kidney. He had an uneventful recovery after HIFU and had no respiratory symptoms immediately before treatment, or at 2 weeks and 6 weeks after treatment during the formal trial visits. The cause was independently verified by local physicians as respiratory failure following pneumonia. As a result, 41 men
Discussion
To our knowledge, our study is the first to assess targeting of individual known cancer areas, with a margin of normal tissue, in men with multifocal as well as unifocal prostate cancer across all cancer-risk categories. Focal therapy of discrete areas of cancer, whether unifocal or multifocal, is feasible, safe, and can be delivered in an ambulatory care setting. Early self-resolving lower urinary-tract symptoms were common. However, the strategy was well tolerated in the genitourinary
References (35)
- et al.
No surgical innovation without evaluation: the IDEAL recommendations
Lancet
(2009) - et al.
Measuring quality of life in men with prostate cancer using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument
Urology
(1997) - et al.
The international index of erectile function (IIEF) a multidimensional scale for assessment of erectile dysfunction
Urology
(1997) Prognostic significance of tumor volume in radical prostatectomy and needle biopsy specimens
J Urol
(2011)- et al.
Characterizing clinically significant prostate cancer using template prostate mapping biopsy
J Urol
(2011) - et al.
The “male lumpectomy”: focal therapy for prostate cancer using cryoablation results in 48 patients with at least 2-year follow-up
Urol Oncol
(2008) - et al.
Focal cryosurgery: encouraging health outcomes for unifocal prostate cancer
Urology
(2007) - et al.
Focal cryosurgery: encouraging health outcomes for unifocal prostate cancer
Urology
(2007) - et al.
Image guided photothermal focal therapy for localized prostate cancer: phase I trial
J Urol
(2009) - et al.
MR to ultrasound registration for image-guided prostate interventions
Med Image Anal
(2012)
Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials
BMJ
Quality of life and satisfaction with outcome among prostate-cancer survivors
N Engl J Med
Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer
Ann Intern Med
Adverse effects of robotic-assisted laparoscopic versus open retropubic radical prostatectomy among a nationwide random sample of medicare-age men
J Clin Oncol
A systematic overview of radiation therapy effects in prostate cancer
Acta Oncol
Transatlantic Consensus Group on active surveillance and focal therapy for prostate cancer
BJU Int
Will focal therapy become a standard of care for men with localized prostate cancer?
Nat Clin Pract Oncol
Cited by (333)
Prediction and Mapping of Intraprostatic Tumor Extent with Artificial Intelligence
2023, European Urology Open ScienceFeasibility of biology-guided radiotherapy using PSMA-PET to boost to dominant intraprostatic tumour
2022, Clinical and Translational Radiation Oncology