Slide 1: ProstaScint-guided Brachytherapy
“ProstaScint®-guided Brachytherapy” Rodney J. Ellis, M.D. Radiation Oncologist Aultman Hospital Canton, Ohio Assistant Professor Urology CASE School of Medicine Cleveland, Ohio
Slide 2: Dose Intensification/Reduction
Dose Intensification/Reduction Urethra Peripheral Zone (100%) Functional imaging with ProstaScint® allows: dose intensification to tumor areas expressing PSMA with concomitant dose reduction to normal radiosensitive tissues Tumor (150%) rectum Neurovascular Bundles
Slide 3: ProstaScint and Dose Escalation
ProstaScint® and Dose Escalation Fig. 1 - CT scan and ProstaScint image fusion showing uptake in right lobe of prostate Fig. 2 - Ultrasound Pre-plan with dose escalation to Biological Target Volume defined by ProstaScint/CT fusion Fig. 3 - 3D reconstruction of Pre-Plan on Rosses STRATA Treatment pla
Slide 4: Patient Example
Patient Example MIMvista fused image sets of ProstaScint® and CT scan showing focal activity in high anterior right base and extending to lateral right apex
Slide 5: Preoperative Ultrasound Planning
Preoperative Ultrasound Planning Base Isodose Color Key: 100% 125% 150% Mid Apex ProstaScint® Defined BTV
Slide 6: Preoperative CT Dosimetry Planning
Preoperative CT Dosimetry Planning Base Isodose Color Key: 100% 150% 200% Mid Apex ProstaScint® Defined BTV
Slide 7: Reconstructions
Reconstructions 3D color wash for both pre-op and post-op studies showing dose escalation to BTV target defined by monoclonal antibody targeting of PSMA (ProstaScint®) within the gland
Slide 8: ProstaScint-Guided Brachytherapy
ProstaScint®-Guided Brachytherapy FEASIBILITY AND ACUTE TOXICITIES OF RADIOIMMUNOGUIDED PROSTATE BRACHYTHERAPY RODNEY J. ELLIS, M.D.,* D. BRUCE SODEE, M.D., JOHN P. SPIRNAK, M.D., KURT H. DINCHMAN, M.D., ANDREW W. O’ LEARY, D.O.,* MICHAEL A. SAMUELS, M.D.,* MARTIN I. RESNICK, M.D., AND TIMOTHY J. KI
Slide 9: 4-Year Outcome
4-Year Outcome Data 80 pts underwent ProstaScint® imaging prior to brachytherapy 13 pts treated with neoadjuvant hormonal therapy Dosimetry guided by ProstaScint localization incorporated into Radiation Therapy planning system 100% 97.4% 89.2% n=20 n=60 n=80 Percent bDFS Cohort Low Risk Intermediate
Slide 10: 5-Year Outcome
5-Year Outcome Data 66 patients with intermediate to high-risk prostate cancer EBRT plus radio-immunoguided brachytherapy 5-year bDFS (ASTRO) 89% Mean follow-up 41 months 100% 89.3% 81.9% n=39 n=27 n=66 Cohort Intermediate Risk High Risk Source: Ellis R, et al. Brachytherapy 2:215-222, 2003.
Slide 11: Data Presented in 2005
Data Presented in 2005 SEVEN YEAR BIOCHEMICAL DISEASE FREE SURVIVAL RATES FOLLOWING PERMANENT PROSTATE BRACHYTHERAPY WITH DOSE ESCALATION TO BIOLOGICAL TUMOR VOLUMES (BTVs) IDENTIFIED WITH SPECT/CT IMAGE FUSION Rodney J. Ellis, M.D.1,5, Edward Kim, M.D.2, Hang Zhou, M.D.1, Pingfu Fu, Ph.D.3, Valdir
Slide 12: Patient & Treatment Characteristics
Patient & Treatment Characteristics n = Mean Std Median Range p-value Follow-up (alive) 53.6 21.6 47.2 24.8, 96.1 Follow-up (deceased) 36.5 19.3 28.8 11.1, 68.9 EBRT+SI - alive 52.7 24.8, 94.7 0.45 SI alone - alive 54.2 47.1 26.3, 96.1 Age (years) 7.9 42, 81 EBRT+SI 7.9 42, 77 0.102 SI alone 7.9 45,
Slide 13: Overall & bDFS for the Whole Group
Overall & bDFS for the Whole Group 88.0% 88.4% 80.4% 82.1% n = Overall survival bDFS (%) by ASTRO bDFS (%) by PSA < 1 mg/ml bDFS (%) by PSA < 0.5 mg/ml Months after implantation
Slide 14: bDFS Stratified by Treatment
bDFS Stratified by Treatment 94.3% 91.5% 77.4% 66.7% 89.6% 66.3% 100 80 60 40 20 0 0 12 24 36 48 60 72 84 96 SI (n=150) EBRT+SI (n=89) p-value=0.0007 bDFS (%) by ASTRO Months after implantation p-value=0.0003 p-value=0.0006 bDFS (%) by PSA<0.5 mg/ml bDFS (%) by PSA<1 mg/ml
Slide 15: bDFS Stratified by Risk Factor
bDFS Stratified by Risk Factor 93.1% 96.0% 80.1% 87.0% 66.3% 72.5% 92.5% 78.6% 64.0% Months after implantation bDFS (%) by ASTRO bDFS (%) by PSA < 1 mg/ml bDFS (%) by PSA < 0.5 mg/ml
Slide 16: bDFS Stratified by Baseline PSA
bDFS Stratified by Baseline PSA 85.6% 90.5% 76.7% 82.6% 83.5% 76.7% Months after implantation bDFS (%) by ASTRO bDFS (%) by PSA < 1 mg/ml bDFS (%) by PSA < 0.5 mg/ml
Slide 17: bDFS Stratified by Hormone Therapy
bDFS Stratified by Hormone Therapy 82.1% 88.5% 86.5% 80.3% 80.4% 80.3% Months after implantation bDFS (%) by ASTRO bDFS (%) by PSA < 1 mg/ml bDFS (%) by PSA < 0.5 mg/ml
Slide 18: bDFS Stratified by ProstaScint
bDFS Stratified by ProstaScint® 87.1% 90.6% 66.1% 45.5% 85.8% 43.8% Months after implantation bDFS (%) by ASTRO bDFS (%) by PSA < 1 mg/ml bDFS (%) by PSA < 0.5 mg/ml
Slide 19: ASTRO Survival Analysis
ASTRO Survival Analysis ASTRO Survival Analysis with Cox Risk Model Variable Hazard ratio Risk ratio (95% CI) P-value Treatment (SI vs. SI+EBRT) 1.1 0.3, 3.8 0.863 Risk factor (Interm. vs. Low) 5.3 1.2, 24.0 0.029 Risk factor (High vs. Low) 8.4 1.5, 49.1 0.017 ProstaScint (local vs. distant) 3.0 1.2
Slide 20: Overall bDFS at 7-Years
ProstaScint®-guided Brachytherapy Overall bDFS at 7-Years Percent bDFS 100 90 80 70 60 50 40 30 20 10 0 88% 82% 80% ASTRO PSA < 1.0 ng/mL PAS < 0.5 ng/mL n=239 Source: Ellis et al. Seven-Year Biochemical Disease-Free Survival Rates Following Permanent Prostate Brachytherapy With Dose escalation to B
Slide 21: Brachytherapy Outcome Data
Brachytherapy Outcome Data Conventional vs. ProstaScint®-Guided Low Risk Intermediate High Risk Meta-analysis1 Duke University 87.4% 5-years range 66%-94% 2,234 patients 74.3% 5-years range 34%-83% 1,224 patients 49.7% 5-years range 15%-69% 416 patients Ellis et al.2 96.0% 7-years 95%CI: 93.6%-98.4%
Slide 22: bDFS at 7-Years by Risk
ProstaScint®-Guided Brachytherapy bDFS at 7-Years by Risk Percent bDFS 95 85 75 65 55 45 Low Risk (n=116) Interm. Risk (n=72) High Risk (n=51) ASTRO PSA<1.0 ng/mL PSA<0.5 ng/mL 5-year historical control rates Source: Ellis et al. Seven-Year Biochemical Disease-Free Survival Rates Following Permanent
Slide 23: Outcome Data
Outcome Data Image Guided Radiation Therapy (IGRT) utilizing ProstaScint® (PSMA- targeting) to define Biological Target Volumes for Brachytherapy results in biochemical Disease Free Survival rates superior to standard implant techniques in low, intermediate, and high risk patients Source: Ellis et a
Slide 24: Outcome Data
Outcome Data ProstaScint® Predicted a Significant Increase in bDFS (ProstaScint lymph node status outside peri-prostatic tissue) 7-yr bDFS Rate (%) by Defined Criteria Lymph node status ASTRO PSA < 1.0 ng/ml PSA < 0.5 ng/ml Negative (-) 90.6% 87.1% 85.8% Positive (+) 66.1% 45.5% 43.8% 239 patients t
Slide 25: Outcome Data
Outcome Data PSMA detection by the ProstaScint® (7E11) antibody has been previously reported to independently predict an increased risk of disease progression following surgery (Ross et al.) The 7-year data for bDFS appears to validate this finding for risk of disease progression in a mature data se