Comparing Treatment Results Of PROSTATE CANCER Prostate Cancer

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Comparing Treatment Results Of PROSTATE CANCER Prostate Cancer Results Study Group 2012 Peter Grimm,

Comparing Treatment Results Of PROSTATE CANCER Prostate Cancer Results Study Group 2012 Peter Grimm, DO Prostate Cancer Center of Seattle 9/26/2020 1

Prostate Cancer Results Study Group Problem: Patients need a simple means to compare the

Prostate Cancer Results Study Group Problem: Patients need a simple means to compare the cancer control rates of modern prostate cancer treatment methods. 9/26/2020 2

Prostate Cancer Results Study Group To solve this problem, we have assembled experts from

Prostate Cancer Results Study Group To solve this problem, we have assembled experts from key treating disciplines: Surgery, External Radiation, Internal (or Brachytherapy), High Frequency Ultrasound, and Proton Therapy The purpose of this work is to do a complete review study of the current literature on prostate cancer treatment 9/26/2020 3

Prostate Cancer Results Study Group Ignace Billiet, MD F. E. B. U. , Urologist

Prostate Cancer Results Study Group Ignace Billiet, MD F. E. B. U. , Urologist Kortrijk, Belgium David Bostwick, MD Bostwick Laboratories David Crawford, MD Univ Colorado, Denver Adam Dicker, MD Thomas Jefferson U Philadelphia, PA Steven Frank, MD MD Andersen, Houston Texas Peter Grimm, DO Prostate Cancer Center of Seattle Jos Immerzeel, MD De Prostaat Kliniek Netherlands Stephen Langley, MD St Luke's Cancer Centre, Guildford England Alvaro Martinez, MD William Beaumont , Royal Oak, Mi Mira Keyes, MD BC Cancer Agency , Vancouver Canada Patrick Kupelian, MD UCLA Med Center Los Angeles Robert Lee , MD Duke University Medical Center Stefan Machtens, MD University Bergisch, Gladbach Germany Jyoti Mayadev, UC Davis , California Brian Moran, MD Chicago Prostate Institute Chicago 9/26/2020 4

Prostate Cancer Results Study Group Gregory Merrick, MD Schiffler Cancer Center Wheeling West Virginia

Prostate Cancer Results Study Group Gregory Merrick, MD Schiffler Cancer Center Wheeling West Virginia Jeremy Millar, MD Alfred Health and Monash University, Melbourne Australia Mack Roach, MD UCSF San Francisco California Richard Stock, MD Mt. Sinai New York Katsuto Shinohara, MD UCSF San Francisco California Mark Scholz, MD Prostate Cancer Research Institute Marina del Ray California Edward Weber, MD Prostate Cancer Center of Seattle Anthony Zietman, MD Harvard Joint Center Boston Ma Michael Zelefsky, MD Memorial Sloan Kettering New York Jason Wong, MD UC Irvine California Stacy Wentworth, MD Piedmont Radiation Oncology Greensboro , NC Robyn Vera, DO Medical College of Virginia Richmond Virginia 9/26/2020 5

ABOUT THIS REVIEW STUDY 21, 000+ prostate studies were published between 2000 and 2011

ABOUT THIS REVIEW STUDY 21, 000+ prostate studies were published between 2000 and 2011 917 of those studies featured treatment results 145 of those met the criteria to be included in this review study. Some treatment methods are underrepresented due to failure to meet criteria 9/26/2020 6

About This Study “Will I be cured? ” or “Will my treatment make me

About This Study “Will I be cured? ” or “Will my treatment make me cancer free? ” are valid patient questions. However, PSA numbers (our best measurement tool today) cannot answer this absolutely. The current state-of-the-art can only indicate that the treatment was “successful” if PSA numbers do not indicate cancer progression. 9/26/2020 7

About This Study After prostate removal, PSA numbers usually fall rapidly to very low

About This Study After prostate removal, PSA numbers usually fall rapidly to very low numbers and stay low. After radiation, PSA numbers usually come down slower, might increase then fall in the 1 to 3 year range (called a “PSA Bump”), and then usually level out at a higher number than the surgery patient. These different PSA expectations result in dissimilar ways to review a man’s PSA history to judge treatment success. This study makes no attempt to standardize those evaluation systems. 9/26/2020 8

Abbreviations Brachy = Seed implantation either permanent or temporary seeds IMRT = Intensity Modulated

Abbreviations Brachy = Seed implantation either permanent or temporary seeds IMRT = Intensity Modulated Radiation Therapy a form of External Radiation RP = Standard open radical prostatectomy Robot RP = Robotic Radical Prostatectomy HIFU = High frequency Ultrasound Cryo= Cryotherapy Protons = form of External Radiation using Protons EBRT= External Beam Radiation Therapy ADT= Hormone Therapy 9/26/2020 9

Criteria for Inclusion of Article* 1. Patients should be separated into Low, Intermediate, and

Criteria for Inclusion of Article* 1. Patients should be separated into Low, Intermediate, and High Risk 2. Success must be determined by PSA analysis 3. All Treatment types considered: Seeds (Brachy), Surgery (Standard or Robotic), IMRT (Intensity Modulated Radiation), HIFU (High Frequency Ultrasound), CRYO (Cryo Therapy), Protons, HDR (High dose Rate Brachytherapy) 4. Article must be in a Peer Reviewed Journal * Expert panel consensus 9/26/2020 10

Criteria for Inclusion of Article (cont. ) 5. Low Risk articles must have a

Criteria for Inclusion of Article (cont. ) 5. Low Risk articles must have a minimum of 100 patients 6. Intermediate Risk articles must have a minimum of 100 patients 7. High Risk articles, because of fewer patients, need only 50 patients to meet criteria 8. Patients must have been followed for a median of 5 years For additional criteria information contact: lisa@prostatecancertc. com 9/26/2020 11

% Articles Meeting Criteria RP EBRT/ IMRT Cryo Brachy/ HDR Robot RP 7. 4%

% Articles Meeting Criteria RP EBRT/ IMRT Cryo Brachy/ HDR Robot RP 7. 4% 10% 6% 19% 3. 2% 23% 3% 2/32 44/236 2/62 3/13 1/31 20/272 26/241 Proton HIFU Total of 917 Treatment Articles. Some articles addressed several treatments and were counted as separate articles for each treatment. 9/26/2020 12

How to Interpret the Results Each treatment is given a symbol. For example Seed

How to Interpret the Results Each treatment is given a symbol. For example Seed implant alone (Brachy) is given a blue dot with a number in it. 27 The number in the symbol refers to the article. The article can be found in the notes section below the slide ( go into “view” in up left corner of Power. Point and click on note section, then click on this portion and scroll down to see all the references) Treatment Success % = Percent of men whose PSA numbers do not indicate cancer progression. (progression free) at a specific point in time The bottom line indicates the number years the study is out An example, the blue dot with 27 inside indicates that, as per article 27, 97% of the patients treated with seeds alone in low risk patients at 12 years were free of disease progression according to PSA numbers 9/26/2020 13

How to Interpret the Results First Establish your clinical risk group* by looking at

How to Interpret the Results First Establish your clinical risk group* by looking at the definitions or ask your physician Refer only to those slides for your risk group Make your own judgment and then ask a doctor in each discipline ( Seeds, External Radiation Surgery, etc) to tell you where his/her own peer reviewed published Treatment Success % would fit on this plot. *Next Slide 9/26/2020 14

 LOW Risk Group Definition Low Risk 9/26/2020 Stage: T 1 or T 2

LOW Risk Group Definition Low Risk 9/26/2020 Stage: T 1 or T 2 a, b Gleason Sum < 6 PSA < 10 ng/ml 15

% PSA Progression Free Treatment Success LOW RISK RESULTS 25 4 22 30 6

% PSA Progression Free Treatment Success LOW RISK RESULTS 25 4 22 30 6 31 19 105 24 23 37 39103 18 102 2 26 40 1 100 27 35 3 33 29 101 38 14 21 13 8 32 10 28 36 EBRT & Seeds 5 16 12 7 104 Robot RP 9 15 CRYO HIFU 34 ← Years from Treatment → Protons HDR 11 • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp. 1) Prostate Cancer Center of Seattle 16

LOW RISK RESULTS Weighted % PSA Progression Free Treatment Success Brachy EBRT 25 4

LOW RISK RESULTS Weighted % PSA Progression Free Treatment Success Brachy EBRT 25 4 22 30 6 31 19 105 24 23 37 39103 18 102 40 1 100 2 26 27 35 3 33 29 101 38 14 21 13 8 32 10 28 36 EBRT & Seeds 5 16 12 7 104 Robot RP 9 15 Surgery 34 ← Years from Treatment → CRYO HIFU Protons HDR 11 • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp. 1) Prostate Cancer Center of Seattle 17

Question about the Criteria “The PCRSG criteria is pretty strict and not a lot

Question about the Criteria “The PCRSG criteria is pretty strict and not a lot of studies fit. What happens if you include articles with only 40 months of follow up or have a long follow up but less than 100 patients? ” 9/26/2020 18

LOW RISK RESULTS 68 51 50 97 66 25 22 4 817562 44 86

LOW RISK RESULTS 68 51 50 97 66 25 22 4 817562 44 86 3069641 82 71 9865 85 72 31 8489 61 93 105 24 1947 % PSA Progression Free Treatment Success >40 months follow-up or less than 100 patients 58 76 56 77 70 80 15 45 59 53 23 46 96 13 8 37 33 29 101 38 78 18 40 1 100 48 3 60 39103 88 102 54 73 2 26 14 21 35 32 1067 28 94 42 95 36 43 55 64 12 83 5 16 7 87 52 104 Seeds & ADT EBRT & Seeds Robot RP 9 41 57 74 79 90 CRYO HIFU 63 34 ← Years from Treatment → 91 + 27 49 11 Protons Hypo EBRT HDR • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 19

LOW RISK RESULTS Weighted >40 months follow-up or less than 100 patients % PSA

LOW RISK RESULTS Weighted >40 months follow-up or less than 100 patients % PSA Progression Free Treatment Success EBRT 68 51 50 92 97 66 25 22 4 817562 44 86 3069641 82 71 6584 85 72 31 98 89 61 93 105 24 1947 58 76 56 77 70 80 15 45 59 53 Brachy 23 46 96 13 8 37 33 29 101 38 78 18 40 1 100 48 3 60 39103 88102 54 73 2 26 14 21 + 27 35 32 1067 28 94 42 95 36 43 55 64 12 83 5 16 52 7 87 104 9 41 57 74 79 Surgery 90 63 34 ← Years from Treatment → 91 Seeds & ADT EBRT & Seeds Robot RP 49 11 CRYO HIFU Protons Hypo EBRT HDR • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 20

Intermediate Risk Patient Definition Zelefsky definition Only 1 factor ▪ Clinical Stage T 2

Intermediate Risk Patient Definition Zelefsky definition Only 1 factor ▪ Clinical Stage T 2 c ▪ Gleason score > 7 ▪ PSA > 10 ng/ml D’Amico definition PSA 10 -20 Gleason Score 7 or Stage T 2 b 9/26/2020 21

% PSA Progression Free Treatment Success INTERMEDIATE RISK RESULTS 33 14 24 2313 35

% PSA Progression Free Treatment Success INTERMEDIATE RISK RESULTS 33 14 24 2313 35 34 15 44 16 4 30 36 45 6 12 43 18 47 19 5 7 Robot RP 37 39 38 42 3 28 9 26 25 29 41 1 8 10 11 40 32 17 27 + Seeds + ADT EBRT & Seeds Hypo EBRT Seeds Alone 2 46 20 HDR ← Years from Treatment → 21 22 EBRT, Seeds + ADT Protons • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 22

INTERMEDIATE RISK RESULTS % PSA Progression Free Treatment Success Weighted EBRT & Seeds Brachy

INTERMEDIATE RISK RESULTS % PSA Progression Free Treatment Success Weighted EBRT & Seeds Brachy 33 14 24 2313 35 34 15 44 16 4 30 36 45 6 12 43 18 47 19 5 7 Robot RP 37 39 EBRT ← Years from Treatment → 38 42 3 28 9 26 25 29 41 1 8 10 11 20 40 32 17 27 + Seeds + ADT EBRT & Seeds Hypo EBRT Seeds Alone 2 46 Surgery 21 22 HDR EBRT, Seeds + ADT Protons • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 23

INTERMEDIATE RISK RESULTS % PSA Progression Free Treatment Success >40 months follow-up or less

INTERMEDIATE RISK RESULTS % PSA Progression Free Treatment Success >40 months follow-up or less than 100 patients 10459 EBRT + ADT 54 56 33 59 55 66 14 79 59 92 98 1544 96 16 4 3036 57 68 69 45 99 77 105 39 82 97 612 51 91 62 18 6393 4347 86 28 74 67 50 90 5 92652 19 78 70 7 25 103 29 76 102 41 100 1 60 8 87 85 88 53 10101 11 75 84 89 94 24 23 13 35 Robot RP 37 34 40 38 58 83 42 73 3 72 71 81 95 65 32 17 27 64 + Seeds + ADT EBRT & Seeds Hypo EBRT Seeds Alone 2 46 20 HDR ← Years from Treatment → 80 21 22 EBRT, Seeds + ADT Protons • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 24

INTERMEDIATE RISK RESULTS weighted Treatment Success % PSA Progression Free >40 months follow-up or

INTERMEDIATE RISK RESULTS weighted Treatment Success % PSA Progression Free >40 months follow-up or less than 100 patients 10459 Brachy 54 56 33 66 55 14 79 92 98 1544 96 57 16 4 68 69 30 36 45 99 77 39 105 82 97 612 51 91 62 18 6393 4347 86 28 74 67 50 90 5 92652 19 78 70 7 25 103 29 76 102 41 100 1 60 8 87 85 88 53 10101 11 75 84 EBRT 89 94 ← Years from Treatment → 80 20 24 23 13 35 Robot RP 37 34 40 38 58 83 42 73 3 72 71 81 95 65 EBRT + ADT 32 17 27 64 + Seeds + ADT EBRT & Seeds Hypo EBRT Seeds Alone 2 46 Surgery 21 22 HDR EBRT, Seeds + ADT Protons • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 25

High Risk Patient Definition Zelefsky definition 2 or more factors Gleason > 7 PSA

High Risk Patient Definition Zelefsky definition 2 or more factors Gleason > 7 PSA 10 -20 Clinical Stage T 1 c- T 2 b D'Amico Gleason Score 8 -10 PSA >20 9/26/2020 26

20 16 19 18 3 22 8 Treatment Success % PSA Progression Free HIGH

20 16 19 18 3 22 8 Treatment Success % PSA Progression Free HIGH RISK RESULTS 40 3 34 9 41 13 36 25 101 106 44 48 1 33 21 4 109 100 108 EBRT & Seed 14 37 47 2 10 12 EBRT & ADT 17 43 32 42 8 110 28 31 Hypo EBRT 104 24 5 39 11 7 6 26 103 35 46 45 Protons HDR 30 27 102 15 105 23 29 ← Years from Treatment → 49 EBRT Seeds + ADT Robot RP • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 27

HIGH RISK RESULTS % PSA Progression Free Treatment Success Weighted EBRT, Seeds & ADT

HIGH RISK RESULTS % PSA Progression Free Treatment Success Weighted EBRT, Seeds & ADT 20 Brachy 16 109 45 19 18 3 22 8 40 3 34 9 41 13 36 25 101 106 EBRT 44 48 1 33 21 4 100 108 17 EBRT & Seeds 43 32 14 42 8 110 28 46 31 Hypo EBRT 104 24 5 39 11 7 6 26 103 35 37 47 2 10 12 EBRT & ADT Surgery 30 27 102 15 105 HDR 23 29 ← Years from Treatment → Protons 49 EBRT Seeds + ADT Robot RP • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) Prostate Cancer Center of Seattle 28

HIGH RISK RESULTS 92 65 81 20 19 18 80 74 78 67 55

HIGH RISK RESULTS 92 65 81 20 19 18 80 74 78 67 55 40 75 3 85 72 54 34 91 66 41 9 7968 71 136436 50 53 25 101 62 106 Treatment Success % PSA Progression Free >40 months follow-up or less than 100 patients 3 22 8 45 4 109 100 108 44 EBRT & Seeds 48 59 56 1 90 33 21 10 12 14 103 35 52 63 73 31 77 46 86 87 88 51 23 29 from 69 Treatment 57 42 8 61 110 89 5 28 Hypo EBRT 104 24 39 11 83 7 8226 6 84 30 58 27 102 15 105 60 Protons HDR 49 EBRT Seeds + ADT Robot RP • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) 37 47 32 2 EBRT & ADT 17 4376 70 ← Years → 16 Prostate Cancer Center of Seattle HIFU 29

HIGH RISK RESULTS Weighted >40 months follow-up or less than 100 patients Treatment Success

HIGH RISK RESULTS Weighted >40 months follow-up or less than 100 patients Treatment Success % PSA Progression Free Brachy 92 65 81 20 19 18 80 74 78 67 55 4075 3 85 72 54 91 66 34 941 68 71 13643679 50 53 25 101 62 106 EBRT ← Years → 3 22 8 16 45 4 109 100 108 17 EBRT & Seed 4376 44 48 59 56 1 90 33 21 70 10 12 14 103 35 52 63 73 31 77 46 86 87 88 51 23 29 from 69 Treatment 57 42 8 61 110 89 5 28 Hypo EBRT 104 24 39 11 83 7 8226 6 84 30 58 27 102 15 105 60 Protons HDR Surgery 49 EBRT Seeds + ADT Robot RP • Prostate Cancer Results Study Group • Numbers within symbols refer to references 9/26/2020 BJU Int, 2012, Vol. 109(Supp 1) 37 47 32 2 EBRT & ADT Prostate Cancer Center of Seattle HIFU 30

 OBSERVATIONS For most low risk patients, most therapies will be successful. There appears

OBSERVATIONS For most low risk patients, most therapies will be successful. There appears to be a higher cancer control success rate for Brachy over EBRT and Surgery for all groups. Patients are encouraged to look at graphs and determine for themselves Serious side effect rates must be considered for any treatment Relaxing the report selection criteria doesn’t seem to impact the results substantially 9/26/2020 31

Slide Symbols & Abbreviations = Seeds alone = EBRT & Seeds = Surgery =

Slide Symbols & Abbreviations = Seeds alone = EBRT & Seeds = Surgery = Standard Radical Prostatectomy = “Robot” =Robotic Prostatectomy = “HIFU” = High Frequency Ultrasound = “HDR”= High Dose Rate Brachytherapy +/-EBRT = EBRT alone = Hypo EBRT = Protons 9/26/2020 32

Slide Symbols & Abbreviations (cont. ) + = “CRYO” Cryo Therapy = EBRT, Seeds,

Slide Symbols & Abbreviations (cont. ) + = “CRYO” Cryo Therapy = EBRT, Seeds, & ADT = Seeds & ADT = EBRT & ADT = “Brachy” = all seed implant treatments = all Surgery treatments = all EBRT & Seeds = all EBRT, Seeds & ADT 9/26/2020 33

 Risk Group Definitions Low Risk Stage: T 1 or T 2 a, b

Risk Group Definitions Low Risk Stage: T 1 or T 2 a, b Gleason Sum < 6 PSA < 10 ng/ml Intermediate Risk Stage T 1 or T 1 -2 Stage T 1 -2 Gleason Score 7 or Gleason 6 PSA < 10 PSA 10 -20 High Risk 9/26/2020 Stage T 2 c or T 3 Gleason score ≥ 8 PSA > 20 ng/m. L 34

For More Information Peter Grimm, DO peter@grimm. com Lisa Grimm, Research Coordinator lisa@prostatecancertc. com

For More Information Peter Grimm, DO peter@grimm. com Lisa Grimm, Research Coordinator lisa@prostatecancertc. com Or Prostate. Cancer. TC. com Or contact PCRSG member Prostate Cancer Treatment Center website www. prostatecancertreatmentcenter. com 9/26/2020 35