Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States.
OBJECTIVE
Vascular targeted photodynamic therapy with WST11 (TOOKAD® Soluble) is a form of tissue ablation that may be used therapeutically for localized prostate cancer. To study dosing parameters and associated treatment effects we performed a prospective, multicenter, phase I/II trial of WST11 vascular targeted photodynamic therapy of prostate cancer.


METHODS
A total of 30 men with unilateral, low volume, Gleason 3 + 3 prostate cancer were enrolled at 5 centers after local institutional review board approval. Light energy, fiber number and WST11 dose were escalated to identify optimal dosing parameters for vascular targeted photodynamic therapy hemi-ablation. Men were treated with photodynamic therapy and evaluated by posttreatment magnetic resonance imaging and biopsy. Prostate specific antigen, light dose index (defined as fiber length/desired treatment volume), toxicity and quality of life parameters were recorded.


RESULTS
After dose escalation 21 men received optimized dosing of 4 mg/kg WST11 at 200 J energy. On posttreatment biopsy residual prostate cancer was found in the treated lobe in 10 men, the untreated lobe in 4 and both lobes in 1. At a light dose index of 1 or greater with optimal dosing in 15 men 73.3% had a negative biopsy in the treated lobe. Six men undergoing retreatment with the optimal dose and a light dose index of 1 or greater had a negative posttreatment biopsy. Minimal effects were observed on urinary and sexual function, and overall quality of life.


CONCLUSIONS
Hemi-ablation of the prostate with WST11 vascular targeted photodynamic therapy was well tolerated and resulted in a negative biopsy in the treated lobe in the majority of men. Dosing parameters and the light dose index appear related to tissue response as determined by magnetic resonance imaging and biopsy. These parameters may serve as the basis for further prospective studies.
Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, New York. Electronic address: samir.taneja@nyumc.org.
Samir S
SS
Taneja
Department of Urology, Emory University Hospital Midtown/Midtown Urology, Atlanta, Georgia.
James
J
Bennett
Department of Urology, Memorial Sloan Kettering Cancer Center, New York, New York.
Jonathan
J
Coleman
Department of Urology, Washington University School of Medicine, St. Louis, Missouri.
Robert
R
Grubb
Department of Urology, Washington University School of Medicine, St. Louis, Missouri.
Gerald
G
Andriole
Department of Urology, University of California at Los Angeles School of Medicine, Los Angeles, California.
Robert E
RE
Reiter
Department of Urology, University of California at Los Angeles School of Medicine, Los Angeles, California.
Leonard
L
Marks
Department of Urology, Centre Hospitalier Universitaire d'Angers, Angers, France.
Abdel-Rahmene
AR
Azzouzi
Division of Surgery and Interventional Science, University College of London, London, United Kingdom.
Mark
M
Emberton
D055011:Ablation Techniques / Q000379:methods*; D000368:Aged; D001429:Bacteriochlorophylls / Q000627:therapeutic use*; D001706:Biopsy; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D010778:Photochemotherapy / Q000379:methods*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D014481:United States
D001429:Bacteriochlorophylls; D017430:Prostate-Specific Antigen; C503696:padeliporfin
WST11 compound; ablation techniques; laser therapy; photochemotherapy; prostatic neoplasms