[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24750-24751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request Therapies for Clinically Localized 
Prostate Cancer

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information Submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from medical device 
manufacturers with products falling within the following UMDNS product 
codes: Brachytherapy Systems [20-352]; Cyclotrons [15-818]; 
Radiotherapy Systems, Linear Accelerator [12-364]; Radiotherapy 
Systems, and Proton Beam [20-546]. Scientific information is being 
solicited to inform the update of our Comparative Effectiveness Review 
of Therapies for Clinically Localized Prostate Cancer which is 
currently being conducted by one of the Evidence-based Practice Centers 
for the AHRQ Effective Health Care Program. Access to published and 
unpublished pertinent scientific information on this device will 
improve the quality of this comparative effectiveness review. AHRQ is 
requesting this scientific information and conducting this comparative 
effectiveness review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173.

DATES: Submission-Deadline-on or-before May 28, 2013.

ADDRESSES:
    Email submissions: src.org">sips@epc-src.org.
    Print submissions:
     Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, PO 
Box 69539, Portland, OR 97239.
     Shipping Address: (FedEx, UPS, etc) Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW US Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Scientific Information 
Packet Coordinator, Telephone: 503-220-8262 x58652 or Email: src.org">sips@epc-src.org.

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency for Healthcare Research and Quality has 
commissioned one of the Effective Health Care (EHC) Program Evidence-
based Practice Centers to complete a comparative effectiveness review 
of the evidence for Therapies for Clinically Localized Prostate Cancer: 
An Update of a 2008 Comparative Effectiveness Review.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information (e.g., 
details of studies conducted) through public information requests, 
including via the Federal Register and direct postal and/or online 
solicitations. We are looking for studies that report on Therapies for 
Clinically Localized Prostate Cancer, including those that describe 
adverse events, as specified in the key questions detailed below. The 
entire research protocol, including the key questions, is also 
available online at: http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1434#7270.
    This notice is a request for information about the following:
     A current product label, if applicable (preferably an 
electronic PDF file).
     Information identifying published randomized controlled 
trials and observational studies relevant to the clinical outcomes. 
AHRQ is interested in receiving both citations and reprints. 
Information identifying unpublished randomized controlled trials and 
observational studies relevant to the clinical outcomes. If possible, 
please provide a summary that includes the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients. 
screened/eligible/enrolled/lost to withdrawn/follow-up/analyzed, and 
effectiveness/efficacy and safety results.
     Registered ClinicalTrials.gov studies. Please provide a 
list including the ClinicalTrials.gov identifier, condition, and 
intervention.
    Your contribution is very beneficial to this-program. This is a-
voluntary-request for information, and all costs for complying with 
this request must be borne by the submitter. You may wish to indicate 
whether or not the submission comprises all of the complete information 
available.
    Please Note: The contents of all submissions, regardless of format, 
will be available to the public upon request unless prohibited by law.
    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.

Scope and Key Questions

    This update examines the same four key questions as in the original 
2008 report on the comparative effectiveness of treatments for 
clinically localized prostate cancer. Although these key questions were 
reviewed and approved by AHRQ and discussed with Technical Expert Panel 
(TEP) members for the

[[Page 24751]]

original report, we presented them for discussion with a newly convened 
TEP for this update and made changes as necessary. This update will 
summarize the more recent evidence comparing the relative effectiveness 
and safety of treatment options for clinically localized prostate 
cancer. The key questions we will address are as follows:

Key Question 1

    What are the comparative risks and benefits of the following 
therapies for clinically localized prostate cancer?
    a. Radical prostatectomy, including open (retropubic and perineal) 
and laparoscopic (with or without robotic assistance) approaches.
    b. External Beam Radiotherapy, including standard therapy and 
therapies designed to decrease exposure to normal tissues such as 3D 
conformal radiation therapy, intensity-modulated radiation therapy, 
proton beam therapy, and stereotactic body radiation therapy.
    c. Interstitial brachytherapy.
    d. Cryosurgery.
    e. Watchful waiting.
    f. Active surveillance.
    g. Hormonal therapy as primary therapy, adjuvant, or neoadjuvant to 
other therapies.
    h. High-intensity focused ultrasound.

Key Question 2

    How do specific patient characteristics (e.g., age, race/ethnicity, 
presence or absence of comorbid illness, preferences such as trade-off 
of treatment-related adverse effects vs. potential for disease 
progression) affect the outcomes of these therapies overall and 
differentially?

Key Question 3

    How do provider/hospital characteristics affect outcomes of these 
therapies overall and differentially (e.g., geographic region, case 
volume, learning curve)?

Key Question 4

    How do tumor characteristics (e.g., Gleason score, tumor volume, 
screen-detected vs. clinically detected tumors, and PSA levels) affect 
the outcomes of these therapies overall and differentially?

Population, Interventions, Comparators, Outcomes, Timing, Settings 
Criteria Population

     Key Questions 1, 2, 3, and 4: Men considered to have 
clinically localized prostate cancer (T1 to T2, N0 to X, M0 to X) 
regardless of age, histologic grade, or PSA level. Articles will be 
excluded if men with disease stage higher than T2 were enrolled and 
outcomes were not stratified by stage.

Interventions

     For Key Questions 1, 2, 3, and 4, we will include 
treatment options for men with clinically localized prostate cancer: 
radical prostatectomy (including retropubic, perineal, laparoscopic, 
robotic-assisted), watchful waiting, active surveillance, External Beam 
Radiotherapy (including conventional radiation, Intensity Modulated 
Radiotherapy, 3D conformal radiation, proton beam, and stereotactic 
body radiation therapy), brachytherapy, androgen deprivation therapy, 
high-intensity focused ultrasound, and cryotherapy.

Comparators

     Any of the interventions of interest above or watchful 
waiting.

Outcomes

     The primary outcome is overall mortality or survival. 
Additional outcomes include prostate-cancer-specific mortality or 
survival, biochemical (PSA) progression, metastatic and/or clinical 
progression-free survival, health status, and quality of life. We will 
focus primarily on common and severe adverse events of treatment 
including bowel, bladder, and sexual dysfunction, as well as harms from 
biopsy such as bleeding and nosocomial infections.
     For Key Question 3, we plan to examine outcomes after 
radical prostatectomy, the most common treatment for localized prostate 
cancer, in association with provider location, case volume, and 
affiliation with academic centers.

Timing

     Duration of follow-up will be appropriate for the outcome 
under consideration.

Settings

     No restrictions by setting.

    Dated: April 15, 2013.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2013-09739 Filed 4-25-13; 8:45 am]
BILLING CODE 4160-90-M