Prostate VTP: Clinical Trial
Update
Katie S. Murray, D.O.
Urological Oncology
April 24, 2015
WST-11
(TOOKAD® SOLUBLE )
• Novel Class of photosensitizers derived
from Chlorophyll
• Non-thermal localized treatment effect
• Water soluble, binds albumin
• Rapid Clearance (t1/2 = 37 minutes)
• IV Administration (4 mg/kg)
• Laser fibers pre-positioned using brachy
template
• Light Activation of WST-11 at 753 nm
• Patient discharged after 6 hours
Clinical Trial Program
TOOKAD® Soluble-WST11
Clinical Trials (Prostate Cancer)
PHASE II
PHASE III
155 patients:
PCM 301 - Europe
Open label study randomized
vs Active Surveillance
PCM 201: 40 patients
(Europe – Canada)
PCM 202: 30 patients
(United States)
PCM203: 85 patients
(Europe)
400 patients (200 /arm)
Recruitment complete (n=413)
PCM 304- Latin America
Open label single arm study
80 patients
Recruitment complete (n=81)
Phase 2 Studies:
Trial Endpoints
• Pathologic
– Negative biopsy in the treated lobe at Month 6
• Serious Adverse Events (SAEs)
– Graded SAEs, QOL (IPSS, IIEF)
• Markers
– Volume of hypoperfusion area shown by MRI at Day 7
– Serum PSA levels and PSA changes from baseline at
6 months
TOOKAD® Soluble Phase II Studies
Phase 2
Studies
Patients treated
unilaterally with
optimal conditions:
Mean %
Necrosis*
4 mg/kg-200 J/cm
Negative
biopsies
n (%)
PCM 201
8
99.0%
7 (87.5%)
PCM 202
15
74.3 %
11 (73.3%)
PCM 203
42
90.7%
34 (81.0%)
All studies
65
87.6%
52 (80.0%)
* Mean % Necrosis = Volume of necrosis/ Vol prostate pre+post treatment/2
TOOKAD® Soluble – Quality of Life Outcomes
Erectile Function and Urinary Symptoms
Mean IIEF-5 score (max = 25) and
Mean IPSS score (max = 35)
Mean Score ( IIEF and IPSS)
25
20
18.8
IIEF score
15.7
15.4
5.6
5.4
15
13.7
10
IPSS score
8.5
5
7.0
Baseline
Month 1
Month 3
Month 6
(n = 149)
(n = 149)
(n = 147)
(n = 150)
TOOKAD® Soluble - Safety profile
Adverse events
Adverse events in phase II patients
treated with 4 mg/kg
N = 117
Dysuria
39 (33.3%)
Perineal pain/Hematoma
18 (15.4%)
Hematuria
16 (13.7%)
Urinary retention
13 (11.1%)
Urinary urgency
11 (9.4%)
Polyuria
9 (7.7%)
Urinary tract infection
7 (6.0%)
Prostatitis
5 (4.3%)
Hematospermia
5 (4.3%)
No Fistulae, No Phototoxicity, No Severe Incontinence
TOOKAD® Soluble Phase II studies
Long term Follow-up
123 Patients in post-study follow-up :
o 95 (77%) patients are still actively followed
o 24 (20%) patients have undergone further whole gland
therapies for prostate cancer, including:
- 16 Radical prostatectomy
- 7 Brachytherapy
- 1 HIFU
o 4 (3%) patients are lost to follow-up
Summary: Phase II Trials
Focal Treatment with WST-11 VTP
Feasible and Safe for Hemiablation and Bilateral Tx
– Efficacy Approx. 80% in treated site (by biopsy)
– Retreatment also suggests ≈ 80% efficacy
– Well Tolerated
• Urinary Function
• Erectile Function
• Adverse Events
– Results of Phase 3 studies anticipated
– Long Term Outcomes are pending (48 mos)