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 !
Leonard S. Marks, M.D.
Professor of Urology
David Geffen School of Medicine at UCLA
Phone: 310-794-3070
Fax:310-794-3060
E-mail: lmarks@mednet.ucla.edu

William D. Steers, M.D.

EDITOR, JOURNAL OF UROLOGY
American Urological Association
1000 Corporate Blvd.
Linthicum, MD 21090

April 27, 2012

RE: “Value of Targeted Biopsy in Detection of Prostate Cancer

Using an Office-Based MR-US Fusion Device”

Dear Bill,
Thanks in advance for taking a careful look at this paper we are now submitting
for publication in Journal of Urology. I sincerely believe this material to be
exceptionally important!

Suggested reviewers might include Peter Pinto at NIH; Hashim Ahmed at

University College Hospital in London; Jelle Barentsz, a radiologist in Nijmegen,
NL; and Samir Taneja at NYU. All are familiar with the concepts, and none
would have a conflict.

The enclosed manuscript describes our work with the first 170 men undergoing
targeted prostate biopsy via MR/US fusion in an office setting. The technology
is a dramatic leap forward, really the most important advance in biopsy technique
since Hodge and Stamey published in 1989. We began working with the
Artemis device in early 2009 and have at this time completed more MR/US fusion
biopsies than any other group (worldwide). All have been done in an office
setting under local anesthesia, using an approach similar to that used now by all
practicing urologists.

The technology is described in a 6 minute online video:

http://www.youtube.com/watch?v=IcLwL2dcK5o
We are including this link as a footnote to the Methods section.
! "!

Imaging of the prostate is of increasing interest to our specialty, but to date, no

one has shown practicing urologists a way to improve prostate imaging and
perform targeted biopsies in their own offices. Until now. The message here
is particularly important, since competition from other specialties for prostate
biopsy is rapidly emerging.

Thanks again for your prompt processing of the paper!

Sincerely,

Leonard S. Marks, M.D.

LSM/cg

!
!
!
!
!
Targeted Biopsy in the Detection of Prostate Cancer using an Office-Based MR-US Fusion
Device
Purpose:

Materials and Methods:

Results:

≥ ≥

Conclusions:
Patients

Multiparametric MRI
MR-US Fusion Biopsy Procedure

Statistical Analysis
 ≥ ≥

≥
≥

≥
≥
 178:

13:

72:

142:

54:

259:

186:

61:

186:

186:

29:
 183:

50:

29:

98:

29:

112:

28:

24:

55:

28:

29:

24:

75:
 167:

166:

185:

176:

Table 1: Classification system for targets identified on MRI.

Figure 1: Sample Case. A.

B.

C.

D and E.

D.

Table 2: Patient Characteristics

Figure 2:

Figure 3:
 The Journal of Urology® Author Submission Requirement Form
TITLE: Value of Targeted Biopsy in Detecting Prostate Cancer using an Office-Based MR-US Fusion Device
Authors: Geoffrey A. Sonn, Shyam Natarajan, Daniel Margolis, Malu Macairan, Patricia Lieu, Jiaoti Huang,
Frederick J. Dorey, Leonard S. Marks

Each author must read and sign (electronic signatures are acceptable) the statements below before manuscripts will
be considered for publication in The Journal of Urology®. Manuscripts submitted without all signatures on all
statements will be returned immediately to the authors. This form is available online at
www.editorialmanager.com/ju. One author should be designated as the correspondent, and the complete
address, telephone number, facsimile number and e-mail address provided.

Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of
data or analysis and interpretation of data; 2) drafting the article or revising it critically for important
intellectual content; AND 3) final approval of the version to be published.

When a large, multicenter group has conducted the work, the group should identify as authors only those
individuals who fulfill the above requirements and accept direct responsibility for the manuscript. The
corresponding author must clearly indicate the preferred citation and identify all individual authors as well
as the group name. Members of the group who are not designated as authors by the corresponding author
will be listed in the Acknowledgments at the end of the manuscript.

I. Authorship Responsibility, Criteria and Contributions

A. By checking the appropriate boxes below, each author certifies that

the manuscript represents valid and original work;

!! the manuscript or portions thereof are not under consideration by another journal or
electronic publication and have not been previously published except as an abstract;
! !the manuscript or portions thereof have been considered previously by The Journal of Urology and/or its
supplements (including joint supplements);
! !if requested I will provide raw data on which the manuscript is based for examination by
the editors and reviewers;
! !if I am the corresponding author I agree to be responsible for indicating the source of
extra-institutional funding, in particular that provided by commercial sources, internal review board
approval of study, accuracy of the references and all statements made in the work, including changes
made by the copy editor, upon review of the proof; or if I am not the corresponding author I agree to
assign the aforementioned responsibilities to the corresponding author;
! !I have read and approve the final manuscript; and
! !I have made a substantive contribution to the information or material submitted for
publication to take public responsibility

B. To qualify for authorship each author must indicate his/her substantive contribution to the intellectual
content of the manuscript by checking a minimum of 1 box for each of the following 3 categories of
contributions

1. ! !Conception and design

! !Data acquisition
! !Data analysis and interpretation
2. ! !Drafting the manuscript
! !Critical revision of the manuscript for scientific and factual content
3. ! Statistical analysis
! !Supervision

! Other (specify) ______________________________________________________

II. Conflict of Interest/Disclosure Policy. Please check the appropriate box below

! !I have no direct or indirect commercial financial incentive associated with publishing the article
! !No funding agreement limits my ability to complete and publish this research/study
! !I have full control of the primary data
! ! I have read and signed the AUA Disclosure Form. Authors employed by the U.S. Federal Government are
exempt from Copyright Transfer.

III. Copyright Transfer. In consideration of the Editors of The Journal of Urology® taking action in reviewing and
editing my submission, the author(s) undersigned hereby transfers, assigns or otherwise conveys all copyright
ownership to the American Urological Association, Inc., Copyright Owner of The Journal of Urology®, in the
event that such work is published in The Journal. All authors have read and comply with the requirements set
forth herein and in the Information for Authors.

_________________________________________________ ___2-29-12___________________
Author Signature Date Signed

The following 2 sections require only the Corresponding Author signature:

IV. Ethical approval of studies.

1.By checking the appropriate boxes the corresponding author certifies that a statement(s)
has been included in the manuscript documenting

! ! Institutional review board, ethics committee or ethical review board study approval
! Institutional animal care and use committee approval
!In lieu of a formal ethics committee, the principles of the Helsinki Declaration were
followed
! All human subjects provided written informed consent with guarantees of
confidentiality

2. IRB approved protocol number is _11-001580_______________

3. Animal approved project number is __N/A___________________

V. Acknowledgment Statement. As corresponding author check the box below that applies:

! ! I certify that all individuals named in an Acknowledgment have given me permission to be named
! ! I certify that no other persons have made substantial contributions to this manuscript to warrant an
Acknowledgement section.

______ _______________ ______2/29/12_____________

Corresponding Author Signature Date Signed
Please return all copies to:
JAMA, 515 N State St, Chicago, IL 60610; (312) 464-5824 (fax)-
Copyright ©2011 by American Urological Association
 The Journal of Urology® Author Submission Requirement Form
TITLE: Value of Targeted Biopsy in Detecting Prostate Cancer using an Office-Based MR-US Fusion Device
Authors: Geoffrey A. Sonn, Shyam Natarajan, Daniel Margolis, Malu Macairan, Patricia Lieu, Jiaoti Huang,
Frederick J. Dorey, Leonard S. Marks

Each author must read and sign (electronic signatures are acceptable) the statements below before manuscripts will
be considered for publication in The Journal of Urology®. Manuscripts submitted without all signatures on all
statements will be returned immediately to the authors. This form is available online at
www.editorialmanager.com/ju. One author should be designated as the correspondent, and the complete
address, telephone number, facsimile number and e-mail address provided.

Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of
data or analysis and interpretation of data; 2) drafting the article or revising it critically for important
intellectual content; AND 3) final approval of the version to be published.

When a large, multicenter group has conducted the work, the group should identify as authors only those
individuals who fulfill the above requirements and accept direct responsibility for the manuscript. The
corresponding author must clearly indicate the preferred citation and identify all individual authors as well
as the group name. Members of the group who are not designated as authors by the corresponding author
will be listed in the Acknowledgments at the end of the manuscript.

I. Authorship Responsibility, Criteria and Contributions

A. By checking the appropriate boxes below, each author certifies that

the manuscript represents valid and original work;

the manuscript or portions thereof are not under consideration by another journal or
electronic publication and have not been previously published except as an abstract;
the manuscript or portions thereof have been considered previously by The Journal of Urology and/or its
supplements (including joint supplements);
if requested I will provide raw data on which the manuscript is based for examination by
the editors and reviewers;
if I am the corresponding author I agree to be responsible for indicating the source of
extra-institutional funding, in particular that provided by commercial sources, internal review board
approval of study, accuracy of the references and all statements made in the work, including changes
made by the copy editor, upon review of the proof; or if I am not the corresponding author I agree to
assign the aforementioned responsibilities to the corresponding author;
I have read and approve the final manuscript; and
I have made a substantive contribution to the information or material submitted for
publication to take public responsibility

B. To qualify for authorship each author must indicate his/her substantive contribution to the intellectual
content of the manuscript by checking a minimum of 1 box for each of the following 3 categories of
contributions

1. Conception and design

Data acquisition
Data analysis and interpretation
2. Drafting the manuscript
Critical revision of the manuscript for scientific and factual content
3. Statistical analysis
Supervision

Other (specify) ______________________________________________________

II. Conflict of Interest/Disclosure Policy. Please check the appropriate box below

I have no direct or indirect commercial financial incentive associated with publishing the article
No funding agreement limits my ability to complete and publish this research/study
I have full control of the primary data
I have read and signed the AUA Disclosure Form. Authors employed by the U.S. Federal Government are
exempt from Copyright Transfer.

III. Copyright Transfer. In consideration of the Editors of The Journal of Urology® taking action in reviewing and
editing my submission, the author(s) undersigned hereby transfers, assigns or otherwise conveys all copyright
ownership to the American Urological Association, Inc., Copyright Owner of The Journal of Urology®, in the
event that such work is published in The Journal. All authors have read and comply with the requirements set
forth herein and in the Information for Authors.

_________________________________________________ ______________________
Author Signature Date Signed

The following 2 sections require only the Corresponding Author signature:

IV. Ethical approval of studies.

1.By checking the appropriate boxes the corresponding author certifies that a statement(s)
has been included in the manuscript documenting

Institutional review board, ethics committee or ethical review board study approval
Institutional animal care and use committee approval
In lieu of a formal ethics committee, the principles of the Helsinki Declaration were
followed
All human subjects provided written informed consent with guarantees of
confidentiality

2. IRB approved protocol number is _11-001580_______________

3. Animal approved project number is __N/A___________________

V. Acknowledgment Statement. As corresponding author check the box below that applies:

I certify that all individuals named in an Acknowledgment have given me permission to be named
I certify that no other persons have made substantial contributions to this manuscript to warrant an
Acknowledgement section.

_____________________________________ ___________________
Corresponding Author Signature Date Signed
Please return all copies to:
JAMA, 515 N State St, Chicago, IL 60610; (312) 464-5824 (fax)-
Copyright ©2011 by American Urological Association
 The Journal of Urology® Author Submission Requirement Form
TITLE: Value of Targeted Biopsy in Detecting Prostate Cancer using an Office-Based MR-US Fusion Device
Authors: Geoffrey A. Sonn, Shyam Natarajan, Daniel Margolis, Malu Macairan, Patricia Lieu, Jiaoti Huang,
Frederick J. Dorey, Leonard S. Marks

Each author must read and sign (electronic signatures are acceptable) the statements below before manuscripts will
be considered for publication in The Journal of Urology®. Manuscripts submitted without all signatures on all
statements will be returned immediately to the authors. This form is available online at
www.editorialmanager.com/ju. One author should be designated as the correspondent, and the complete
address, telephone number, facsimile number and e-mail address provided.

Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of
data or analysis and interpretation of data; 2) drafting the article or revising it critically for important
intellectual content; AND 3) final approval of the version to be published.

When a large, multicenter group has conducted the work, the group should identify as authors only those
individuals who fulfill the above requirements and accept direct responsibility for the manuscript. The
corresponding author must clearly indicate the preferred citation and identify all individual authors as well
as the group name. Members of the group who are not designated as authors by the corresponding author
will be listed in the Acknowledgments at the end of the manuscript.

I. Authorship Responsibility, Criteria and Contributions

A. By checking the appropriate boxes below, each author certifies that

x the manuscript represents valid and original work;

x the manuscript or portions thereof are not under consideration by another journal or
electronic publication and have not been previously published except as an abstract;
the manuscript or portions thereof have been considered previously by The Journal of Urology and/or its
supplements (including joint supplements);
x if requested I will provide raw data on which the manuscript is based for examination by
the editors and reviewers;
if I am the corresponding author I agree to be responsible for indicating the source of
extra-institutional funding, in particular that provided by commercial sources, internal review board
approval of study, accuracy of the references and all statements made in the work, including changes
made by the copy editor, upon review of the proof; or if I am not the corresponding author I agree to
assign the aforementioned responsibilities to the corresponding author;
x I have read and approve the final manuscript; and
x I have made a substantive contribution to the information or material submitted for
publication to take public responsibility

B. To qualify for authorship each author must indicate his/her substantive contribution to the intellectual
content of the manuscript by checking a minimum of 1 box for each of the following 3 categories of
contributions

1. x Conception and design

x Data acquisition
x Data analysis and interpretation
2. Drafting the manuscript
x Critical revision of the manuscript for scientific and factual content
3. Statistical analysis
Supervision

Other (specify) ______________________________________________________

II. Conflict of Interest/Disclosure Policy. Please check the appropriate box below

x I have no direct or indirect commercial financial incentive associated with publishing the article
x No funding agreement limits my ability to complete and publish this research/study
x I have full control of the primary data
x I have read and signed the AUA Disclosure Form. Authors employed by the U.S. Federal Government are
exempt from Copyright Transfer.

III. Copyright Transfer. In consideration of the Editors of The Journal of Urology® taking action in reviewing and
editing my submission, the author(s) undersigned hereby transfers, assigns or otherwise conveys all copyright
ownership to the American Urological Association, Inc., Copyright Owner of The Journal of Urology®, in the
event that such work is published in The Journal. All authors have read and comply with the requirements set
forth herein and in the Information for Authors.

__ ______________________________________ _____02/29/12________________
Author Signature Date Signed

The following 2 sections require only the Corresponding Author signature:

IV. Ethical approval of studies.

1.By checking the appropriate boxes the corresponding author certifies that a statement(s)
has been included in the manuscript documenting

Institutional review board, ethics committee or ethical review board study approval
Institutional animal care and use committee approval
In lieu of a formal ethics committee, the principles of the Helsinki Declaration were
followed
All human subjects provided written informed consent with guarantees of
confidentiality

2. IRB approved protocol number is _11-001580_______________

3. Animal approved project number is __N/A___________________

V. Acknowledgment Statement. As corresponding author check the box below that applies:

I certify that all individuals named in an Acknowledgment have given me permission to be named
I certify that no other persons have made substantial contributions to this manuscript to warrant an
Acknowledgement section.

_____________________________________ ___________________
Corresponding Author Signature Date Signed
Please return all copies to:
JAMA, 515 N State St, Chicago, IL 60610; (312) 464-5824 (fax)-
Copyright ©2011 by American Urological Association
 American Urological Association (AUA) Disclosure Statement (January-December 2012)
In order to ensure proper balance, independence, objectivity, and scientific rigor in all AUA educational and governance activities,
individuals participating in such activities are expected to disclose their private financial or institutional interests related to health care
or to AUA activities, business transactions, presentations or publications. AUA does not view the existence of these interests or
commitments as necessarily implying bias or decreasing the value of participation in organization activities. The intent of disclosure is
to allow others to make an informed decision about the existence and impact of potential conflicts -- including the necessity for recusal
or disqualification under extraordinary circumstances.

Name AUA ID#

Please indicate all areas of current AUA participation.

Annual Meeting Faculty Board/Committee Member Official Representative Journal/Abstract

Reviewers

OE Course Faculty JU Author Consultant Other

OE Author/Editor AUA News Author Section Meeting Faculty

Please consider your AUA activities and provide below disclosure of possibly conflicting material interests or commitments
based on the following relationships.
Affiliation. Membership on the board of directors, officership, editorial position, or status as a paid employee or paid or non-paid consultant in
any health-related or business concern, including any health publishing, internet or e-commerce entity.
Ownership. Significant personal holdings in any commercial entity, including any publishing, internet, e-commerce or other business interest that
provides products or services related to health care or to AUA activities. For purposes of this policy, “significant” means an ownership interest of
five percent (5%) or more of stock or assets of the commercial entity; or an equity interest of $25,000 or more in the commercial entity.
Compensation. Support from commercial or other sources, including any publishing, internet or e-commerce organizations, related to health care
or to AUA activities. Significant income includes stock options in, royalty arrangements with, or dividends from the commercial entity,
anticipated to produce more than $2,500 in annual income, or payment for speaking engagements from that entity (exclusive of reimbursable
travel costs) in excess of $2,500 in any twelve-month period.
If these criteria do not apply to you, please leave the following section blank and sign below.

COMPANY/ PERSON ROLE

(Self, Family, Board Member, Consultant/Advisor, Employee,
DATE OF DISCLOSURE REPORTED Investigator,Owner, Investor, Meeting Participant/
Business Partner) Lecturer, Scientific Study/Trial, Other (specify)

I have read this Disclosure Statement and understand that failure to comply with the disclosure policy shall be considered cause for
sanctions, which may include: removal of an AUA member from office or appointment, exclusion from participation in the affected
AUA activity, when known or deliberate, disqualification for two years from participation in similar AUA educational or related
activities, and where egregious, expulsion from AUA or other sanctions prescribed by Article X of the AUA Bylaws. To the best of
my knowledge, the information provided in this form represents all items for Disclosure as of the date provided.

February 29, 2012

Signature Date

Please return signed form to: AUA, Publications Department, 1000 Corporate Blvd. Linthicum, MD 21090 (FAX: 410-689-
3906)

See AUANET.org for complete text of the AUA Disclosure/Conflict of Interest Policy.
 American Urological Association (AUA) Disclosure Statement (January-December 2012)
In order to ensure proper balance, independence, objectivity, and scientific rigor in all AUA educational and governance activities,
individuals participating in such activities are expected to disclose their private financial or institutional interests related to health care or to
AUA activities, business transactions, presentations or publications. AUA does not view the existence of these interests or commitments as
necessarily implying bias or decreasing the value of participation in organization activities. The intent of disclosure is to allow others to
make an informed decision about the existence and impact of potential conflicts -- including the necessity for recusal or disqualification
under extraordinary circumstances.

Name Daniel J A Margolis, MD AUA ID#

Please indicate all areas of current AUA participation.

Annual Meeting Faculty Board/Committee Member Official Representative Journal/Abstract

Reviewers

OE Course Faculty JU Author Consultant Other

OE Author/Editor AUA News Author Section Meeting Faculty

Please consider your AUA activities and provide below disclosure of possibly conflicting material interests or commitments
based on the following relationships.
Affiliation. Membership on the board of directors, officership, editorial position, or status as a paid employee or paid or non-paid consultant in any
health-related or business concern, including any health publishing, internet or e-commerce entity.
Ownership. Significant personal holdings in any commercial entity, including any publishing, internet, e-commerce or other business interest that
provides products or services related to health care or to AUA activities. For purposes of this policy, “significant” means an ownership interest of five
percent (5%) or more of stock or assets of the commercial entity; or an equity interest of $25,000 or more in the commercial entity.
Compensation. Support from commercial or other sources, including any publishing, internet or e-commerce organizations, related to health care or to
AUA activities. Significant income includes stock options in, royalty arrangements with, or dividends from the commercial entity, anticipated to produce
more than $2,500 in annual income, or payment for speaking engagements from that entity (exclusive of reimbursable travel costs) in excess of $2,500
in any twelve-month period.
If these criteria do not apply to you, please leave the following section blank and sign below.

COMPANY/ PERSON ROLE

(Self, Family, Board Member, Consultant/Advisor, Employee,
DATE OF DISCLOSURE REPORTED Investigator,Owner, Investor, Meeting Participant/
Business Partner) Lecturer, Scientific Study/Trial, Other (specify)

Siemens Medical Systems Self Research Grant Recipient

I have read this Disclosure Statement and understand that failure to comply with the disclosure policy shall be considered cause for
sanctions, which may include: removal of an AUA member from office or appointment, exclusion from participation in the affected AUA
activity, when known or deliberate, disqualification for two years from participation in similar AUA educational or related activities, and
where egregious, expulsion from AUA or other sanctions prescribed by Article X of the AUA Bylaws. To the best of my knowledge, the
information provided in this form represents all items for Disclosure as of the date provided.

Signature Date

Please return signed form to: AUA, Publications Department, 1000 Corporate Blvd. Linthicum, MD 21090 (FAX: 410-689-3906)

See AUANET.org for complete text of the AUA Disclosure/Conflict of Interest Policy.
 American Urological Association (AUA) Disclosure Statement (January-December 2012)
In order to ensure proper balance, independence, objectivity, and scientific rigor in all AUA educational and governance activities,
individuals participating in such activities are expected to disclose their private financial or institutional interests related to health care or to
AUA activities, business transactions, presentations or publications. AUA does not view the existence of these interests or commitments as
necessarily implying bias or decreasing the value of participation in organization activities. The intent of disclosure is to allow others to
make an informed decision about the existence and impact of potential conflicts -- including the necessity for recusal or disqualification
under extraordinary circumstances.

Name Leonard S. Marks, M.D. AUA ID# 305777

Please indicate all areas of current AUA participation. J.U. Author, Reviewer

! Annual Meeting Faculty ! Board/Committee Member ! Official Representative ! Journal/Abstract

Reviewers

! OE Course Faculty ! JU Author ! Consultant ! Other

! OE Author/Editor ! AUA News Author ! Section Meeting Faculty
Please consider your AUA activities and provide below disclosure of possibly conflicting material interests or commitments
based on the following relationships.
Affiliation. Membership on the board of directors, officership, editorial position, or status as a paid employee or paid or non-paid consultant in any
health-related or business concern, including any health publishing, internet or e-commerce entity.
Ownership. Significant personal holdings in any commercial entity, including any publishing, internet, e-commerce or other business interest that
provides products or services related to health care or to AUA activities. For purposes of this policy, “significant” means an ownership interest of five
percent (5%) or more of stock or assets of the commercial entity; or an equity interest of $25,000 or more in the commercial entity.
Compensation. Support from commercial or other sources, including any publishing, internet or e-commerce organizations, related to health care or to
AUA activities. Significant income includes stock options in, royalty arrangements with, or dividends from the commercial entity, anticipated to produce
more than $2,500 in annual income, or payment for speaking engagements from that entity (exclusive of reimbursable travel costs) in excess of $2,500
in any twelve-month period.
If these criteria do not apply to you, please leave the following section blank and sign below.

COMPANY/ PERSON ROLE

(Self, Family, Business Board Member, Consultant/Advisor, Employee,
DATE OF DISCLOSURE REPORTED Investigator,Owner, Investor, Meeting Participant/
Partner) Lecturer, Scientific Study/Trial, Other (specify)

None

I have read this Disclosure Statement and understand that failure to comply with the disclosure policy shall be considered cause for
sanctions, which may include: removal of an AUA member from office or appointment, exclusion from participation in the affected AUA
activity, when known or deliberate, disqualification for two years from participation in similar AUA educational or related activities, and
where egregious, expulsion from AUA or other sanctions prescribed by Article X of the AUA Bylaws. To the best of my knowledge, the
information provided in this form represents all items for Disclosure as of the date provided.

February 29, 2012

Signature Date

See AUANET.org for complete text of the AUA Disclosure/Conflict of Interest Policy.