The Prostate Cancer Results Study Group was formed to compare and share results from modern prostate cancer treatments in the absence of randomized studies. The group reviewed over 15,000 articles from 2000-2009 and identified 603 treatment results articles that met their inclusion criteria. These articles were analyzed and the results were compiled into graphs showing PSA progression-free survival rates for different treatments over time, stratified by low, intermediate, and high risk patient groups. The analysis found that brachytherapy alone or in combination appeared superior to other treatments in all risk groups based on standard reporting criteria. However, few studies to date stratified patients into recognized risk groups or conformed to basic reporting requirements.

1. Peter Grimm, DO
Seattle Prostate Institute
Latest update 4/23/09

2.  Problem: In the absence of randomized
studies, patients, physicians, carriers,
Medicare, etc: need a means to compare the
effectiveness of modern treatments
 Purpose: The PCRSG will compare and share
results for prostate cancer that are utilizable
for all those who are interested
11/4/2014 2

3.  Ignace Billiet,MD Europe
 David Bostwick, MD Bostwick Laboratories
 David Crawford, MD Univ Colorado
 Peter Grimm, DO Seattle
 Jos Immerzeel, Netherlands
 Mira Keyes, MD BC Cancer Agency
 Kupelian, Patrick, MD MD Anderson Orlando
 Robert Lee Duke University Medical Center
 Brian Moran, MD Chicago Prostate Institute
 Greg Merrick, MD Schiffler Cancer Center
 Jeremy Millar, MD Australia
 Mack Roach, MD UCSF
11/4/2R01i4chard Stock, MD Mt. Sinai New York 3

4.  Katsuto Shinohara, MD UCSF
 John Sylvester, MD SPI
 Mark Scholz, MD Prostate Cancer Research Institute
 Ed Weber, MD SPI
 Anthony Zietman, MD Harvard Joint Center
 Michael Zelefsky, MD Memorial Sloan Kettering
 Fellows Jason Wong, MD
 Residents:
 Jyoti Mayadev, MD University of Washington
 Stacy Wentworth, MD Wake forest
 Robyn Vera, DO Medical College of Virginia
11/4/2014 4

5.  >15,000 articles reviewed from 2000-2009
 Pub Med, Medline, Google Scholar,
Elsevier search
 603 Treatment Results Articles Identified
 Expert Panel Established Criteria for
Inclusion
 Treatment Articles screened for study
group criteria

6. 1. Patients must be stratified into recognizable
Pre-Treatment Risk groups: Low, Intermediate,
and High Risk by either D’Amico, Zelefsky or
NCCN stratification
2. bRFS standard endpoint ASTRO, Phoenix, and
PSA < 0.2 (surgery)
3. Clinical Staging No exclusions: i.e. No Pathologic
staging
4. EBRT must be minimum 72 Gy IMRT / conformal
11/4/2014 6

7. 5. All Treatment modalities considered: Seeds,
Surgery, IMRT, HIFU, CRYO Protons, HDR
6. Accepted results: Peer Reviewed Journals Only
7. Low Risk Accepted minimum number 100 pts
8. Int Risk Accepted minimum number 100 pts
9. High Risk Accepted minimum number 50 pts
10. Minimum median F/U : 5 yr
11/4/2014 7

8. RP EBRT Cryo Brachy Robot
RP
Proton HIFU
15/206 7/165 2/26 20/157 0/53 1/9 0/27
7% 4% 8% 13% 0% 11% 0%
Total 603 Treatment Articles. Some articles addressed several treatments
11/4/2014 8

9. 8 14
7
100
90
80
70
60
3
13
12
24
17
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Brachy
Surgery
EBRT
5
22
16
← Years →
CRYO
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
No TX
2
23
HIFU
% PSA Progression Free
20
11
15
Protons
21
4
18
19
9
10
EBRT &
Seeds
13
25
Robot RP
26
11/4/2014 9

10. 8 14
7
100
90
80
70
60
3
13
12
24
17
Brachy
Surgery
EBRT
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Brachy
Surgery
EBRT
5
22
16
← Years →
CRYO
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
No TX
2
23
HIFU
% PSA Progression Free
20
11
15
Protons
21
4
18
19
9
10
EBRT &
Seeds
13
25
Robot RP
26
11/4/2014 10

11. 11/4/2014 11

12. 100
90
80
70
60
50
51
45
17
13 12
45
66
4
63
266 5
61
25
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Robot RP
Brachy
Surgery
EBRT
5
41
49
43
52 16
3
1
7
47
14
23
8
2
22
% Progression Free
46
11
15
58
57 46
59
60
48 21
18
54
19
9
10
44
47
55
62
24
56
67
CRYO
HIFU
Protons
No TX
62
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 12

13. 100
90
80
70
60
50
51
45
17
13 12
45
66
4
63
266 5
61
Brachy
EBRT
Surgery
25
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Robot RP
Brachy
Surgery
EBRT
5
41
49
43
52 16
3
1
7
47
14
23
8
2
22
% Progression Free
46
11
15
58
57 46
59
60
48 21
18
54
19
9
10
44
47
55
62
24
56
67
CRYO
HIFU
Protons
No TX
62
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 13

14. 100
90
80
70
60
50
40
27 19
33
15
4 36
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Brachy
Surgery
EBRT
CRYO
HIFU
29
30
23
16
21
5
26
31
6
% PSA Progression Free
18
12
28
3
17
7
14 32
9
8
2
25
35
34
1
13
Protons
HDR
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 14

15. 100
90
80
70
60
50
40
27 19
33
15
4 36
Brachy
EBRT
Surgery
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Brachy
Surgery
EBRT
CRYO
HIFU
29
30
23
16
21
5
26
31
6
% PSA Progression Free
18
12
28
3
17
7
14 32
9
8
2
25
35
34
1
13
Protons
HDR
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 15

16. 5353
100
90
80
70
60
50
40
27 19
58
7
15
35
36
77
18
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Brachy
Surgery
EBRT
CRYO
HIFU
29
30
23
16
21
5
51
26
72
13
67
31
6
1
%PSA Progression Free
12
61
28
3
53
17
60
59
56
57
73
14
54
9
8
2
25
4
52
62
63
3 32
65
4
68 69
70
71
64
34
48
74
75
76
80
78
Protons
HDR
79
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 16

17. 5353
100
90
80
70
60
50
40
27 19
58
7
15
35
36
74
77
Brachy
EBRT
Surgery
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
Seeds
Brachy
Surgery
EBRT
CRYO
HIFU
29
30
23
16
21
5
51
26
72
13
67
31
6
1
%PSA Progression Free
18
12
61
28
3
53
17
60
59
56
57
73
14
54
9
8
2
25
4
52
62
63
3 32
65
4
68 69
70
71
64
34
48
75
76
80
78
Protons
HDR
79
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 17

18. 100
90
80
70
60
50
40
30
20
5
27
37
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
ADT
EBRT &
Seeds
Brachy
Surg
EBRT
Cryo
6
11
36
13
3
25
15
31
EBRT
Seeds +
ADT
19
23
30
16
10
20
18
33
29
7
% PSA Progression Free
4
17
32
14
21
8
2
1
9
22
24
26
28
34
38
39
41
37
41
12
Protons
HDR
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 18

19. 100
90
80
70
60
50
40
30
20
37
Brachy
23
EBRT
Surgery
13
20
32
5
27
26
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
ADT
EBRT &
Seeds
Brachy
Surg
EBRT
Cryo
6
11
36
3
25
15
31
EBRT
Seeds +
ADT
19
30
16
10
18
33
29
7
% PSA Progression Free
4
17
14
21
8
2
1
9
22
24
28
34
38
39
41
37
41
12
Protons
HDR
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 19

20. 54
84
53
100
90
80
70
60
50
40
30
20
70
5
27
37
73
82
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
ADT
EBRT &
Seeds
Brachy
Surg
EBRT
Cryo
64
6
11
36
13 57
3
25
15
56
31
60
16
23
30
55
59
20 18
19
33
29
7
% PSA Progression Free
4
17
32
72
50
61
14
21
8
62
12
58
2
1
9
22
24
26
28
34
38
39
51
52
63
65
67 66
68
69
Seeds + HT
40
76
74
75
71
787 7
79
80
81
83
41
85
37
41
10
HDR
EBRT
Seeds +
ADT
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 20

21. 54
84
77
53
100
90
80
70
60
50
40
30
20
70
5
27
37
82
Brachy
EBRT
24
37
Surgery
38
73
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
EBRT &
ADT
EBRT &
Seeds
Brachy
Surg
EBRT
Cryo
64
6
11
36
13 57
3
25
15
56
31
60
16
23
30
55
59
20 18
19
33
29
7
% PSA Progression Free
4
17
32
72
50
61
14
21
8
62
12
58
2
1
9
22
26
28
34
39
51
52
63
65
67 66
68
69
Seeds + HT
40
76
74
75
71
78
79
80
81
83
41
85
41
10
HDR
EBRT
Seeds +
ADT
← Years →
• Prostate Cancer Results Study Group 3/31/09
• Numbers within symbols refer to references
11/4/2014 21

22.  No Randomized studies to date
 By BRFS control criteria Brachytherapy
alone or Comb appears superior in all risk
groups
 Prostate studies to date rarely include Pre-treatment
Risk Group stratification,
confounding comparisons
 Only a small % of studies to date conform to
basic reporting criteria
11/4/2014 22

23. 1-877-773-0622
www.studymanager.com
11/4/2014 23

24. Anne Grilley
11/4/2014 24