Findings from a 5-year extension of a phase 3 trial of men with low-risk prostate cancer (low risk prostate cancer is defined as having ≤3 positive cores with a maximum cancer core length of 3 to 5 mm on biopsy) showed that men who received a single dose of vascular-targeted photodynamic therapy (VTP) significantly reduced disease progression compared to active surveillance.
These findings were presented at the Virtual 35th Annual Congress of the European Association of Urology (EAU).
In the trial, the men were randomized to either active surveillance (n = 206) or a single dose of partial gland ablation using VTP (n = 207).
VTP consisted of a single session in which padeliporfin was administered intravenously, followed by insertion of optical fibers into the prostate gland. Laser light was shone through the fibers into the prostate, with partial gland ablation as the goal.
The primary endpoint was time to disease progression in the intent-to-treat population at the 5-year point. Data were available for 62% of men in the active surveillance group and 68% of men in the VTP group.
After five years, a higher proportion of the participating men in the active surveillance group (68%) were found to experience a disease progression event compared with the VTP-treated patients (38%).
The median time to disease progression of 13.8 months among men in the active surveillance arm, but in the VTM arm, there is still has not been a period reached.
At the 2-year point, the absolute risk reduction for disease progression among VTP-treated patients compared with the active surveillance group was 35% using Kaplan-Meier estimates, 36% at 3 years, and 32% at 4 and finally 30% at 5 years.
[Presentation title: 5-Year Progression Results From a Phase-3 Prospective Randomized Trial of Vascular-Targeted Photo-Therapy Versus Active Surveillance for Low-Risk Prostate Cancer. Abstract 888]
