Padeliporfin vascular-targeted photodynamic therapy may be preferable to active surveillance for patients with low-risk, localized prostate cancer, according to a study published in The Lancet Oncology.1
In many cases of low-risk prostate cancer, active surveillance is appropriate: patients may have favorable outcomes, though it is not uncommon that a treatment intervention is required. For this phase 3 trial (ClinicalTrials.gov Identifier: NCT01310894), researchers evaluated whether this experimental focal therapy would reduce the risk of disease progression or need for radical therapy in contrast with active surveillance.
Of 413 enrolled patients, 206 were randomized to the focal therapy (experimental arm) and 207 were randomized to active surveillance; 185 patients from the experimental arm and 174 patients in the surveillance arm completed 24 months’ follow-up.
At month 24, 28% of all patients randomized to the experimental arm had disease progression; this figure was 58% for patients randomized to the surveillance arm. Observed cases of progression in both arms involved any of the following: more than 3 positive cores, a Gleason pattern of at least 4, disease core length of more than 5mm, or a prostate-specific antigen (PSA) score of more than 10ng/mL for 3 or more consecutive tests. There were also 4 cases of T3 disease in the surveillance arm vs none in the experimental arm.
Nearly half of patients in the experimental arm had a negative biopsy result at 24 month’s follow-up; this was observed for only 14% of patients in the surveillance arm.
No single grade 3 or 4 adverse event occurred in more than 2% of either arm. The authors noted, however, that the focal therapy did increase the odds of any adverse event occurring.
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These results show, according to the study’s authors, that padeliporfin vascular-targeted photodynamic therapy is a safe and effective treatment option in this patient population, and may be “implemented widely.”
- Azzouzi AR, Vincendeau S, Barret E, et al. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2016 Dec 19. doi: 10.1016/S1470-2045(16)30661-1 [Epub ahead of print]