Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
Summary
The aims of this study are: * to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and * to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
Timeline
- Start
- 2011-02
- Primary completion
- 2015-06
- Completion
- 2015-08
Outcome
Met primary endpoint
paper disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) PMID 28007457 ↗
paper adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p<0·0001 PMID 28007457 ↗
Publications
- Results Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. 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. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.
- Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.
- Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad(R) Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Padeliporfin | Other / unclassified | 4 mg/kg | Intravenous |