Slide 1: Evolving Role and Clinical Impact of ProstaScint
“Evolving Role and Clinical Impact of ProstaScint®” Michael J. Manyak, MD, FACS Vice President, Medical Affairs CYTOGEN Corp
Slide 2: ProstaScint
ProstaScint® Early development Positive predictive value modest Findings difficult to interpret without training Significance of midabdominal signal Importance of negative predictive value not appreciated Limitations due to imaging technology, not the antibody
Slide 3: Radioimmunoscintigraphy Advances
Radioimmunoscintigraphy Advances Significant improvements in resolution Image co-registration Outcomes data Image-guided therapy
Slide 4: Models for Prediction
Models for Prediction PSA doubling time may suggest metastasis but does not give location or extent of disease Nomogram prediction of lymph node metastasis based on path samples from very limited lymph node areas
Slide 5: Standard Imaging Inadequate
Standard Imaging Inadequate CT, MRI poor sensitivity PET poor sensitivity No tissue confirmation studies Surgical LN Sampling Invasive Samples only small area
Slide 6: Surgical Lymph Node Sampling
Surgical Lymph Node Sampling Samples only a small area LN Extended Stone 1997 7.3% 23% Heidenreich 2002 12% 26% Bader 2002 24% 11% in low risk patients Complications 22% (open), 5% (Lap PLND)
Slide 7: Surgery
Surgery Extended LN dissection still only samples selected areas 4.5% of LN in APR for colorectal cancer were actually prostate cancer (Murray, Am J Surg Path, 2004) Extended LN dissection misses disease 43% 5 yr progression free rate (Allaf, J Urol 2004) 39% 4 yr progression free rate rate (Bader,
Slide 8: ProstaScint Image Fusion
ProstaScint® Image Fusion Fusion imaging combines anatomic and functional information Anatomic information can be obtained from either CT or MRI Molecular imaging with ProstaScint may reveal abnormalities earlier than anatomical changes
Slide 9: ProstaScint: Then and Now
ProstaScint®: Then and Now Present Past… Traditional ProstaScintSPECT image - without correction Fusion of CT and enhanced ProstaScint Separate CT scan, providing anatomical information Same ProstaScint image with attenuation & scatter correction Note: 71- yr old white male w/ post bilateral nerve s
Slide 10: ProstaScint Fusion Imaging
ProstaScint® Fusion Imaging CT + ProstaScint CT Alone Bowel identified Bowel activity Internal iliac area looks normal Internal iliac area looks abnormal
Slide 11: Value of Image Co-Registration
Value of Image Co-Registration Schettino et al., AJR 2004 58 pts, 74 of 161 + sites actually (–) 25 pts thought to be + were really (–) with fusion Wong et al., AJR 2005 Image quality improved and interpretation simplified with fusion images Better antibody localization using fusion images Sodee et
Slide 12: ProstaScint Outcomes Data
ProstaScint® Outcomes Data CAU- CAU+ 15.0% 10.0% 5.0% 0.0% CAU- CAU+ 4-year Death Rate 341 patients with at least two years of clinical follow-up 69 patients (20%) exhibited positive central abdominal uptake (CAU+) Haseman MK, Kipper S, Rosenthal SA. Multifocal capromab penedetide (ProstaScint®) upt
Slide 13: ProstaScint Outcomes Data
ProstaScint® Outcomes Data CAU- CAU+ p-value Patients Deaths (all) 14 (5%) 10 (14.5%) p = 0.09 Deaths (cancer) 2 (0.8%) 5 (7.3%) p = 0.01 Androgen block 205 (60%) (17%) No androgen 67 (20%) 12 (3%) p = 0.2 Significantly higher death rate from prostate cancer in central abdominal uptake (CAU) positiv
Slide 14: Advantage to use of Fused Images
Advantage to use of Fused Images Jani et al. J Nuc Med 2004 107 pts, 3 yr biochemical free survival 85% versus 71% Only fused scans used for treatment plan significant (p=0.04) Schild et al. RSNA abstract 2004 43 pts, coregistration to increase or decrease dose Low toxicity, preliminary PSA data
Slide 15: Imaging: Clinical Outcomes
Imaging: Clinical Outcomes PSMA overexpression: Twice the occurrence and rate of biochemical recurrence (Ross, Clin CA Res, 2003) Fused images: 83% sensitivity, tissue confirmed, doubled localization accuracy (Sodee,Clin Prost CA 2005) Central abdominal signal: 3 fold increase in death (Haseman, 200