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Four-year follow-up of a phase-3 prospective randomized trial of vascular-targeted phototherapy vs active surveillance for low-risk prostate cancer

The Journal of Urology Apr 11, 2018

Gill I, et al. - Researchers reported 4-year oncologic outcomes and post-hoc biopsy analysis of a phase 3 prospective randomized trial wherein 413 men with low-risk prostate cancer (PCa) (= 3 positive cores, 3-5 mm max cancer core length) were randomized to partial gland ablation (PGA) with vascular-targeted photodynamic therapy (VTP; n=207) or active surveillance (AS; n=206). The European Medicines Agency’s Committee for Medicinal Products for Human Use recently (09/2017) approve VTP for unilateral low, but not very low, risk PCa considering two-year data (Lancet Oncol. 2017;18:181). In this first and only prospective RCT evaluating focal therapy for prostate cancer, a significant attenuation in progression, overall and in grade, was achieved with VTP. Cross over to radical therapy was reported for fewer VTP men. This is a clinically-meaningful benefit that lowers treatment-related morbidity.

Methods
  • Rates of crossover to radical therapy (RT), and metastasis-free, cancer-specific and overall survival rates were assessed as 4-year outcomes.
  • Overall progression and spatial distribution of post-VTP biopsy findings were assessed via post-hoc analysis.

Results
  • Follow-up of 3 and 4-year was available in 69% & 64% of men, respectively.
  • Data showed lower rates of crossover to RT in VTP men at 2 years (7% vs 33%), 3 years (14% vs 44%) and 4 years (24% vs 53%) (HR=0.31, 95% CI=0.21-0.45; p<0.001), yielding an absolute risk reduction for RT at 2, 3 and 4 years in the VTP arm of 26%, 30% and 29%, respectively, vs AS.
  • Between cohorts, similar 4-year metastasis-free (99% vs 99%), cancer-specific (100% vs 100%) and overall survival (98% vs 99%) rates were found.
  • The VTP cohort showed lower overall progression (HR=0.35; 95% CI=0.25-0.48, p<0.001) and progression in grade (HR=0.42; 95% CI=0.29-0.59, p<0.001) at 2 years.
  • Findings demonstrated similar negative biopsy rates in the apex (72%), mid-gland (78%), and base (74%) after VTP treatment, indicating VTP’s ability to consistently ablate various spatial locations throughout the prostate.
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