Supplemental Evidence and Data Request on Therapies for Clinically Localized Prostate Cancer, 49304-49305 [2019-20303]

Download as PDF 49304 Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices access, utilization, cost, safety, and quality of hospital, physician, and other services. Disseminates data, tools, and statistics to facilitate and inform public and private health policy analysis, clinical studies, and socioeconomic research to inform public and private healthcare policy. Division of Survey Operations (DSO): Responsible for the MEPS data collection, processing and distribution activities. These responsibilities include directing data collection for the three major MEPS surveys, preparing data files for public use, conducting workshops on the appropriate use of MEPS data and the development of a website for disseminating MEPS products. Publishes statistical briefs, research findings and a series of methodological reports. Administers a data center at which researchers can, with approved projects and under specific technical controls and privacy protocols, access data that cannot be released to the public for use in specific research activities. Maintains liaisons with individuals and organizations engaged in health services research both within and outside the federal government. All delegations and redelegations of authority to officers and employees of the Agency for Healthcare Research and Quality that were in effect immediately prior to the effective date of this reorganization shall continue in effect pending further redelegation provided they are consistent with this reorganization. These changes are effective upon date of signature. Dated: September 18, 2019. Gopal Khanna, Director. [FR Doc. 2019–20218 Filed 9–18–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Therapies for Clinically Localized Prostate Cancer Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions. jbell on DSK3GLQ082PROD with NOTICES AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on SUMMARY: VerDate Sep<11>2014 17:30 Sep 18, 2019 Jkt 247001 Therapies for Clinically Localized Prostate Cancer, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline: Comments must be received on or before 30 days after date of publication of this notice. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Therapies for Clinically Localized Prostate Cancer. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC 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 from the public (e.g., details of studies conducted). We are looking for studies that report on Therapies for Clinically Localized Prostate Cancer, including those that describe adverse events. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ prostate-cancer-therapies/protocol. This is to notify the public that the EPC Program would find the following information on Therapies for Clinically Localized Prostate Cancer helpful: D A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 D For completed studies that do not have results on ClinicalTrials.gov, a summary, including 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 follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website 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: https:// www.effectivehealthcare.ahrq.gov/ email-updates. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. Key Questions KQ 1: What are the comparative effectiveness and harms of CLPC therapies? (1) Watchful waiting (2) Active surveillance (3) Androgen deprivation therapy (ADT) (4) Focal therapies (a) Brachytherapy (b) Cryotherapy (c) High-intensity focused ultrasound (HIFU) (d) Laser ablation E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices (e) Photodynamic therapy (f) Irreversible electroporation (5) Whole gland therapies (a) Brachytherapy (b) Cryotherapy (c) External beam radiation therapy (i) three-dimensional conformal radiotherapy (ii) intensity-modulated radiation therapy (iii) proton beam therapy (iv) stereotactic body radiation therapy (d) Radical prostatectomy (i) open (ii) laparoscopic (1) without robotic assistance (2) with robotic assistance (6) Combination of above KQ 2: How do patient characteristics modify comparative effectiveness and harms of CLPC therapies? (1) Age (2) Race/ethnicity (3) Comorbidities (4) Health status KQ 3: How do tumor characteristics modify comparative effectiveness and harms of CLPC therapies? (1) Baseline PSA (2) Gleason score (3) Tumor index scores (e.g., Cancer of the Prostate Risk Assessment Score [CAPRA], D’Amico Risk Classification for Prostate Cancer, etc.) (4) Biomarker Status (a) Decipher (Genomic Classifier) (b) Oncotype Dx (Genomic Prostate Score) (c) Prolaris (Cell Cycle Progression) KQ 4: How do provider/hospital characteristics modify comparative effectiveness of RP compared to other therapies? (1) Geographic region (2) Hospital type (3) Provider volume (4) Institutional volume PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Interventions KQ1 to 3 jbell on DSK3GLQ082PROD with NOTICES (1) Radical prostatectomy (RP) Comparators KQ1 to KQ4 • Any other intervention of listed above except certain within category comparisons (e.g., nerve-sparing vs non-nerve sparing prostatectomy; different dosage/frequency/timing/ duration of same therapy) (1) Watchful waiting (WW) (2) Active surveillance (AS) (3) Androgen deprivation therapy (ADT) (4) Focal therapies (a) Brachytherapy (b) Cryotherapy (c) High-intensity focused ultrasound Jkt 247001 KQ1 to KQ3 • Overall survival/mortality • Prostate cancer specific survival/ mortality • Metastatic-progression free survival • Metastases (lymph nodes/distant) • Health status • Quality of life (measured with validated instruments) • Prostate-cancer related quality of life (measured with validated instruments) KQ4 • Overall survival/mortality • Prostate cancer specific survival/ mortality • Metastatic free survival/metastases (lymph nodes/distant) Common and serious treatment side effects: • Bowel, bladder, and sexual/erectile dysfunction • Serious adverse effects associated with ADT such as cognitive impairment, MACE, fractures Timing KQ1 to KQ3 Follow up from treatment initiation: PO 00000 Frm 00061 • Mortality/survival outcomes/ metastases: 5 years or more • Health status, quality of life and harms: 1 year or more KQ4 Follow up from treatment initiation: • Mortality/survival outcomes/ metastases: 5 years or more Setting KQ1 to KQ4 • All settings Study Design KQ1 to KQ4 (1) RCTs (2) Non-RCT if: (a) Comparative (b) Concurrent (c) Multicenter (enrolling patients treated at multiple locations) (d) ≥500 patients (e) Some method to control for selection bias (propensity scores, instrumental variables, multivariate regression) (f) Prospective data collection Dated: September 16, 2019. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–20303 Filed 9–18–19; 8:45 am] BILLING CODE 4160–90–P Outcomes KQ1 to KQ3 • Treatment naı¨ve men with CLPC (stages T1 to T3) 17:30 Sep 18, 2019 KQ4 Harms Population(s) VerDate Sep<11>2014 (HIFU) (d) Laser ablation (e) Photodynamic therapy (f) Irreversible electroporation (5) Whole gland therapies (a) Brachytherapy (b) Cryotherapy (c) External beam radiation therapy (i) Three-dimensional conformal radiotherapy (ii) Intensity-modulated radiation therapy (iii) Proton beam therapy (iv) Stereotactic body radiation therapy (d) Radical prostatectomy (i) Open (ii) Laparoscopic (1) Without robotic assistance (2) With robotic assistance (6) Combination of above 49305 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review: Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (New Collection) Office of Planning, Research, and Evaluation; ACF; HHS ACTION: Request for public comment. AGENCY: The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new study, Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS). DATES: Comments due within 30 days of publication. OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. SUMMARY: E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49304-49305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Therapies for 
Clinically Localized Prostate Cancer

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

ACTION: Request for supplemental evidence and data submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Therapies for 
Clinically Localized Prostate Cancer, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: 
    Submission Deadline: Comments must be received on or before 30 days 
after date of publication of this notice.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Therapies for 
Clinically Localized Prostate Cancer. AHRQ is conducting this 
systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).
    The EPC 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 from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Therapies for Clinically Localized Prostate Cancer, 
including those that describe adverse events. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/prostate-cancer-therapies/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Therapies for Clinically Localized Prostate 
Cancer helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including 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 follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website 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: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions

    KQ 1: What are the comparative effectiveness and harms of CLPC 
therapies?

(1) Watchful waiting
(2) Active surveillance
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
    (a) Brachytherapy
    (b) Cryotherapy
    (c) High-intensity focused ultrasound (HIFU)
    (d) Laser ablation

[[Page 49305]]

    (e) Photodynamic therapy
    (f) Irreversible electroporation
(5) Whole gland therapies
    (a) Brachytherapy
    (b) Cryotherapy
    (c) External beam radiation therapy
    (i) three-dimensional conformal radiotherapy
    (ii) intensity-modulated radiation therapy
    (iii) proton beam therapy
    (iv) stereotactic body radiation therapy
    (d) Radical prostatectomy
    (i) open
    (ii) laparoscopic
    (1) without robotic assistance
    (2) with robotic assistance
(6) Combination of above

    KQ 2: How do patient characteristics modify comparative 
effectiveness and harms of CLPC therapies?

(1) Age
(2) Race/ethnicity
(3) Comorbidities
(4) Health status

    KQ 3: How do tumor characteristics modify comparative effectiveness 
and harms of CLPC therapies?

(1) Baseline PSA
(2) Gleason score
(3) Tumor index scores (e.g., Cancer of the Prostate Risk Assessment 
Score [CAPRA], D'Amico Risk Classification for Prostate Cancer, etc.)
(4) Biomarker Status
    (a) Decipher (Genomic Classifier)
    (b) Oncotype Dx (Genomic Prostate Score)
    (c) Prolaris (Cell Cycle Progression)

    KQ 4: How do provider/hospital characteristics modify comparative 
effectiveness of RP compared to other therapies?

(1) Geographic region
(2) Hospital type
(3) Provider volume
(4) Institutional volume

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population(s)

 Treatment na[iuml]ve men with CLPC (stages T1 to T3)

Interventions

KQ1 to 3
(1) Watchful waiting (WW)
(2) Active surveillance (AS)
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
    (a) Brachytherapy
    (b) Cryotherapy
    (c) High-intensity focused ultrasound (HIFU)
    (d) Laser ablation
    (e) Photodynamic therapy
    (f) Irreversible electroporation
(5) Whole gland therapies
    (a) Brachytherapy
    (b) Cryotherapy
    (c) External beam radiation therapy
    (i) Three-dimensional conformal radiotherapy
    (ii) Intensity-modulated radiation therapy
    (iii) Proton beam therapy
    (iv) Stereotactic body radiation therapy
    (d) Radical prostatectomy
    (i) Open
    (ii) Laparoscopic
    (1) Without robotic assistance
    (2) With robotic assistance
(6) Combination of above
KQ4
(1) Radical prostatectomy (RP)

Comparators

KQ1 to KQ4
 Any other intervention of listed above except certain within 
category comparisons (e.g., nerve-sparing vs non-nerve sparing 
prostatectomy; different dosage/frequency/timing/duration of same 
therapy)

Outcomes

KQ1 to KQ3
 Overall survival/mortality
 Prostate cancer specific survival/mortality
 Metastatic-progression free survival
 Metastases (lymph nodes/distant)
 Health status
 Quality of life (measured with validated instruments)
 Prostate-cancer related quality of life (measured with 
validated instruments)
KQ4
 Overall survival/mortality
 Prostate cancer specific survival/mortality
 Metastatic free survival/metastases (lymph nodes/distant)

Harms

KQ1 to KQ3
    Common and serious treatment side effects:

 Bowel, bladder, and sexual/erectile dysfunction
 Serious adverse effects associated with ADT such as cognitive 
impairment, MACE, fractures

Timing

KQ1 to KQ3
    Follow up from treatment initiation:

 Mortality/survival outcomes/metastases: 5 years or more
 Health status, quality of life and harms: 1 year or more
KQ4
    Follow up from treatment initiation:

 Mortality/survival outcomes/metastases: 5 years or more

Setting

KQ1 to KQ4
 All settings

Study Design

KQ1 to KQ4
(1) RCTs
(2) Non-RCT if:
    (a) Comparative
    (b) Concurrent
    (c) Multicenter (enrolling patients treated at multiple locations)
    (d) >=500 patients
    (e) Some method to control for selection bias (propensity scores, 
instrumental variables, multivariate regression)
    (f) Prospective data collection

    Dated: September 16, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-20303 Filed 9-18-19; 8:45 am]
BILLING CODE 4160-90-P