Supplemental Evidence and Data Request on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review, 3218-3220 [2025-00547]
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3218
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
TABLE 2—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA: KEY QUESTIONS 5 AND
6 ON SPECIFIC PROCEDURES IN PATIENTS WITH CHRONIC LOW BACK PAIN DUE TO DEGENERATIVE SPINE DISEASE—
Continued
Inclusion
Study designs ...............................................................
Exclusion
KQ 5
• RCTS for effectiveness/efficacy outcomes
• Prospective NRSIs that control for confounding
will be considered for effectiveness in the absence of RCTs
• NRSIs for harms must be specifically designed
to evaluate/report on serious AE/harms and
that control for confounding OR focused on
rare or long-term harms
KQ 6
• Predictive/prognostic modeling studies evaluating the association of procedure response
impact on outcomes that control for confounding
KQ 5,
•
•
•
6
NRSI that do not control for confounding
NRSI that include historical controls
NRSI with fewer than 50 patients per treatment arm
• Case reports, case-series, single-arm and prepost studies
• Publication types: Conference abstracts or
proceedings, editorials, letters, white papers,
citations that have not been peer-reviewed,
single site reports of multi-site studies
• Studies not in English
Serious adverse events are defined as events that are life-threatening or anything needing additional medical attention. AE = adverse event; DLS = degenerative
lumbar spondylolisthesis; EQ–5D = EuroQol 5D scale; ESI = epidural steroid injection; FDA = Food and Drug Administration; IONM = intraoperative neuro monitoring;
KQ = Key Question; LBP = low back pain; MCID = minimum clinically important difference; NRSI = nonrandomized studies of intervention; ODI = Oswestry Disability
Index; RCT = randomized controlled trial; RF = radiofrequency ablation; RMD = Rolland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness Data; SF–36/12 = Short Form 36 or 12 questionnaire; VAS = visual analog scale.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025–00548 Filed 1–13–25; 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 Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submission.
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
Primary Hypofractionated Radiation
Therapy for Localized Prostate Cancer:
A Systematic Review, 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 on or
before February 13, 2025.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality, Attn:
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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22:42 Jan 13, 2025
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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:
Kelly Carper, Telephone: 301–427–1656
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 Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review.
AHRQ is conducting this review
pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
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 Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review.
The entire research protocol is available
online at: https://effectivehealthcare.
ahrq.gov/products/hypofractionatedradiation-therapy/protocol.
This is to notify the public that the
EPC Program would find the following
information on Primary
Hypofractionated Radiation Therapy for
Localized Prostate Cancer: A Systematic
Review helpful:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
D A list of completed studies that your
organization has sponsored for this
topic. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements, if relevant: 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
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, 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 topic 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 topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
E:\FR\FM\14JAN1.SGM
14JAN1
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
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://effectivehealthcare.ahrq.gov/
email-updates.
The 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)
KQ 1: For patients with localized
prostate cancer receiving external beam
radiation therapy (EBRT) with curative
intent, what are the benefits and harms
of moderate hypofractionation
compared to conventional fractionation?
KQ 1a: Do findings vary with respect
to patient characteristics (e.g., age, race
and ethnicity), pretreatment
characteristics (e.g., risk group, prostate
gland volume, lower urinary tract
symptoms, prior prostate procedures),
treatment targets (i.e., prostate with or
without treatment of pelvic lymph
nodes), and use of adjunctive therapies
(e.g., with or without neoadjuvant or
adjuvant androgen deprivation
therapy)?
KQ 2: For patients with localized
prostate cancer receiving EBRT with
curative intent, what are the benefits
and harms of ultra-hypofractionation
compared to moderate
hypofractionation or conventional
fractionation?
KQ 2a: Do findings vary with respect
to patient characteristics (e.g., age, race,
and ethnicity), pretreatment
characteristics (e.g., risk group, prostate
gland volume, lower urinary tract
symptoms, prior prostate procedures),
treatment targets (i.e., prostate with or
without treatment of pelvic lymph
nodes), and use of adjunctive therapies
(i.e., with or without neoadjuvant or
adjuvant androgen deprivation
therapy)?
KQ 3: For patients with localized
prostate cancer receiving moderate or
ultra-hypofractionated EBRT with
curative intent, what are the benefits
and harms of different dosefractionation regimens?
KQ 3a: Do findings vary with respect
to pretreatment characteristics (i.e.,
tumor stage, disease risk, urinary tract
symptoms, prior prostate procedures)?
KQ 4: For patients with localized
prostate cancer receiving moderate or
ultra-hypofractionated EBRT with
curative intent, what are the benefits
and harms associated with different
target volumes (i.e., prostate alone,
prostate with seminal vesicles, prostate
with seminal vesicles and pelvic lymph
nodes; with or without focal
intraprostatic boosts)?
KQ 4a: Do findings vary with respect
to pretreatment characteristics (i.e.,
imaging)?
KQ 5: For patients with localized
prostate cancer receiving moderate
or ultra-hypofractionated EBRT
with curative intent, what are the
benefits and harms of different
treatment planning and delivery
techniques?
Contextual Question
Does the utilization of fractionation
schedule (i.e., conventional
fractionation, moderate
hypofractionation, and ultrahypofractionation) differ by factors such
as age, race, ethnicity, socioeconomic
status, or geography?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
Inclusion criteria
Exclusion criteria
KQs 1–5. Adult aged ≥18 years with localized prostate cancer (stages T1 to T4N0M0) who
have elected to receive EBRT as their primary treatment regardless of pretreatment characteristics.
KQs 1a, 2a: Consider patient characteristics (e.g., age, race and ethnicity), pretreatment
characteristics (e.g., prostate cancer risk group, prostate gland volume, presence of lower
urinary tract symptoms), use of adjunctive therapies (e.g., androgen deprivation therapy).
All KQs. Radiation therapy administered as a primary treatment ..............................................
KQ 1. MHF (2.4 to 3.4 Gy per fraction).
KQ 2. UHF (≥5.0 Gy per fraction).
KQ 3. Various dose-fractionation regimens (MHF, UHF).
KQ 4. Various target volumes (MHF, UHF) (e.g., prostate, seminal, vesicles, pelvic lymph
nodes, focal intraprostatic boosts).
KQ 5. Various treatment planning and delivery techniques.
• Advanced imaging for target delineation (any pretreatment imaging, i.e., CT, MRI, MRlinac, PET, urethral contrast).
• Dose-volume criteria for OARs (urethra).
• Image-guidance techniques (i.e., cone-beam CT, intraprostatic fiducial markers, MRI, electromagnetic tracking).
• Delivery techniques (i.e., IMRT, VMAT [term ARCS] protons [IMPT, passive scatter],
SBPT, SBRT/SABR, 3D CRT).
• Rectal-sparing technologies (e.g., rectal spacers).
• Online adaptive radiotherapy (treatment planning software).
• Patient preparation for treatment planning and daily treatment (e.g., daily enemas, full
bladder, empty rectum).
KQ 1. CF (1.8 to 2.0 Gy per fraction) .........................................................................................
KQ 2. CF, MHF.
KQ 3. Dose-fractionation regimens compared to each other.
KQ 4. Target volumes compared to each other [all grouped by type of hypofractionation
(MHF and UHF).
KQ 5. Treatment planning and delivery techniques compared to each other
KQ 1—KQ 5. Overall and prostate cancer-specific survival, local recurrence, metastases,
biochemical recurrence-free survival, acute and late gastrointestinal toxicity, acute and late
genitourinary toxicity, patient reported outcomes (i.e., GI, GU, ED) and quality of life.
Any followup duration ..................................................................................................................
Individuals aged <18 years,
those with non-localized
stage of prostate cancer
at enrollment.
Preliminary PICOTS criteria
Population .............
Interventions .........
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Comparators .........
Outcomes .............
Timing ...................
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Other treatments and techniques. Salvage radiation
therapy; adjuvant or
neoadjuvant radiation
therapy.
Other comparators.
Other outcomes.
NA
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
Setting ...................
Study Design ........
Inclusion criteria
Exclusion criteria
KQ 1—KQ 5. All clinical settings .................................................................................................
KQs 1, 2. Randomized controlled trials ......................................................................................
KQs 3–5. Randomized controlled trials. Comparative cohort studies with concurrent control
groups, conducted within the same clinical setting. Other observational studies with concurrent control groups, that control for confounders.
Studies conducted in countries rated as very high on the Human Development Index.a
NA
KQs 1, 2: Other designs.
KQs 3–5: Uncontrolled cohort studies, case-control
studies, case reports,
case series, cost-effectiveness and other modeling studies.
Studies using nonconcurrent comparators (e.g.,
historical controls).
Studies comparing methods
across different settings/
clinics.
Observational studies that
do not control for confounders.
Abbreviations: CF = conventionally fractionated external beam radiation therapy; CT = computed tomography; CRT = conventional radiotherapy; EBRT = external beam radiation therapy; ED = erectile dysfunction; GI = gastrointestinal issues; GU = genitourinary issues; Gy = gray;
IMPT = intensity modulated proton therapy; KQ = key question; MHF = moderately hypofractionated radiation therapy; MRI = magnetic resonance imaging; MR-linac = MRI-guided linear accelerator; NA = not applicable; OARs = organs at risk; PET = positron emission tomography; PICOTS = population, interventions, comparators, outcomes, timing, and setting; SABR = stereotactic ablative radiotherapy; SBPT = stereotactic
body proton therapy; SBRT = stereotactic body radiation therapy; UHF = ultra-hypofractionated radiation therapy; VMAT = volumetric modulated
arc therapy.
a United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/data-center/human-developmentindex#/indicies/HDI.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025–00547 Filed 1–13–25; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10777, CMS–
R–235 and CMS–10662]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
March 17, 2025.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10777 Conditions of Participation
for Intermediate Care Facilities for
Individuals with Intellectual
Disabilities (ICFs-IID)
CMS–R–235 Data Use Agreement
(DUA) Limited Data Set (LDS) Forms
Research Identifiable Files (FIF)
Forms
CMS–10662 Administrative
Simplification HIPAA Compliance
Review
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
E:\FR\FM\14JAN1.SGM
14JAN1
Agencies
[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3218-3220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00547]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Primary
Hypofractionated Radiation Therapy for Localized Prostate Cancer: A
Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submission.
-----------------------------------------------------------------------
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 Primary
Hypofractionated Radiation Therapy for Localized Prostate Cancer: A
Systematic Review, 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 on or before February 13, 2025.
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: Kelly Carper, Telephone: 301-427-1656
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 Primary
Hypofractionated Radiation Therapy for Localized Prostate Cancer: A
Systematic Review.
AHRQ is conducting this review pursuant to Section 902 of the
Public Health Service Act, 42 U.S.C. 299a.
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 Primary Hypofractionated Radiation Therapy for Localized
Prostate Cancer: A Systematic Review. The entire research protocol is
available online at: https://effectivehealthcare.ahrq.gov/products/hypofractionated-radiation-therapy/protocol.
This is to notify the public that the EPC Program would find the
following information on Primary Hypofractionated Radiation Therapy for
Localized Prostate Cancer: A Systematic Review helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, if
relevant: 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 topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, 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 topic 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 topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying
[[Page 3219]]
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://effectivehealthcare.ahrq.gov/email-updates.
The 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)
KQ 1: For patients with localized prostate cancer receiving
external beam radiation therapy (EBRT) with curative intent, what are
the benefits and harms of moderate hypofractionation compared to
conventional fractionation?
KQ 1a: Do findings vary with respect to patient characteristics
(e.g., age, race and ethnicity), pretreatment characteristics (e.g.,
risk group, prostate gland volume, lower urinary tract symptoms, prior
prostate procedures), treatment targets (i.e., prostate with or without
treatment of pelvic lymph nodes), and use of adjunctive therapies
(e.g., with or without neoadjuvant or adjuvant androgen deprivation
therapy)?
KQ 2: For patients with localized prostate cancer receiving EBRT
with curative intent, what are the benefits and harms of ultra-
hypofractionation compared to moderate hypofractionation or
conventional fractionation?
KQ 2a: Do findings vary with respect to patient characteristics
(e.g., age, race, and ethnicity), pretreatment characteristics (e.g.,
risk group, prostate gland volume, lower urinary tract symptoms, prior
prostate procedures), treatment targets (i.e., prostate with or without
treatment of pelvic lymph nodes), and use of adjunctive therapies
(i.e., with or without neoadjuvant or adjuvant androgen deprivation
therapy)?
KQ 3: For patients with localized prostate cancer receiving
moderate or ultra-hypofractionated EBRT with curative intent, what are
the benefits and harms of different dose-fractionation regimens?
KQ 3a: Do findings vary with respect to pretreatment
characteristics (i.e., tumor stage, disease risk, urinary tract
symptoms, prior prostate procedures)?
KQ 4: For patients with localized prostate cancer receiving
moderate or ultra-hypofractionated EBRT with curative intent, what are
the benefits and harms associated with different target volumes (i.e.,
prostate alone, prostate with seminal vesicles, prostate with seminal
vesicles and pelvic lymph nodes; with or without focal intraprostatic
boosts)?
KQ 4a: Do findings vary with respect to pretreatment
characteristics (i.e., imaging)?
KQ 5: For patients with localized prostate cancer receiving
moderate or ultra-hypofractionated EBRT with curative intent, what are
the benefits and harms of different treatment planning and delivery
techniques?
Contextual Question
Does the utilization of fractionation schedule (i.e., conventional
fractionation, moderate hypofractionation, and ultra-hypofractionation)
differ by factors such as age, race, ethnicity, socioeconomic status,
or geography?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
------------------------------------------------------------------------
Exclusion
Inclusion criteria criteria
------------------------------------------------------------------------
Preliminary PICOTS criteria
------------------------------------------------------------------------
Population.................... KQs 1-5. Adult aged Individuals aged
>=18 years with <18 years,
localized prostate those with non-
cancer (stages T1 to localized stage
T4N0M0) who have of prostate
elected to receive cancer at
EBRT as their primary enrollment.
treatment regardless
of pretreatment
characteristics.
KQs 1a, 2a: Consider
patient
characteristics
(e.g., age, race and
ethnicity),
pretreatment
characteristics
(e.g., prostate
cancer risk group,
prostate gland
volume, presence of
lower urinary tract
symptoms), use of
adjunctive therapies
(e.g., androgen
deprivation therapy).
Interventions................. All KQs. Radiation Other treatments
therapy administered and techniques.
as a primary Salvage
treatment. radiation
KQ 1. MHF (2.4 to 3.4 therapy;
Gy per fraction).. adjuvant or
KQ 2. UHF (>=5.0 Gy neoadjuvant
per fraction).. radiation
KQ 3. Various dose- therapy.
fractionation
regimens (MHF, UHF)..
KQ 4. Various target
volumes (MHF, UHF)
(e.g., prostate,
seminal, vesicles,
pelvic lymph nodes,
focal intraprostatic
boosts)..
KQ 5. Various
treatment planning
and delivery
techniques..
Advanced
imaging for target
delineation (any
pretreatment imaging,
i.e., CT, MRI, MR-
linac, PET, urethral
contrast)..
Dose-volume
criteria for OARs
(urethra)..
Image-
guidance techniques
(i.e., cone-beam CT,
intraprostatic
fiducial markers,
MRI, electromagnetic
tracking)..
Delivery
techniques (i.e.,
IMRT, VMAT [term
ARCS] protons [IMPT,
passive scatter],
SBPT, SBRT/SABR, 3D
CRT)..
Rectal-
sparing technologies
(e.g., rectal
spacers)..
Online
adaptive radiotherapy
(treatment planning
software)..
Patient
preparation for
treatment planning
and daily treatment
(e.g., daily enemas,
full bladder, empty
rectum)..
Comparators................... KQ 1. CF (1.8 to 2.0 Other
Gy per fraction). comparators.
KQ 2. CF, MHF.........
KQ 3. Dose-
fractionation
regimens compared to
each other..
KQ 4. Target volumes
compared to each
other [all grouped by
type of
hypofractionation
(MHF and UHF)..
KQ 5. Treatment
planning and delivery
techniques compared
to each other.
Outcomes...................... KQ 1--KQ 5. Overall Other outcomes.
and prostate cancer-
specific survival,
local recurrence,
metastases,
biochemical
recurrence-free
survival, acute and
late gastrointestinal
toxicity, acute and
late genitourinary
toxicity, patient
reported outcomes
(i.e., GI, GU, ED)
and quality of life.
Timing........................ Any followup duration. NA
[[Page 3220]]
Setting....................... KQ 1--KQ 5. All NA
clinical settings.
Study Design.................. KQs 1, 2. Randomized KQs 1, 2: Other
controlled trials. designs.
KQs 3-5. Randomized KQs 3-5:
controlled trials. Uncontrolled
Comparative cohort cohort studies,
studies with case-control
concurrent control studies, case
groups, conducted reports, case
within the same series, cost-
clinical setting. effectiveness
Other observational and other
studies with modeling
concurrent control studies.
groups, that control Studies using
for confounders.. nonconcurrent
Studies conducted in comparators
countries rated as (e.g.,
very high on the historical
Human Development controls).
Index.\a\. Studies
comparing
methods across
different
settings/
clinics.
Observational
studies that do
not control for
confounders.
------------------------------------------------------------------------
Abbreviations: CF = conventionally fractionated external beam radiation
therapy; CT = computed tomography; CRT = conventional radiotherapy;
EBRT = external beam radiation therapy; ED = erectile dysfunction; GI
= gastrointestinal issues; GU = genitourinary issues; Gy = gray; IMPT
= intensity modulated proton therapy; KQ = key question; MHF =
moderately hypofractionated radiation therapy; MRI = magnetic
resonance imaging; MR-linac = MRI-guided linear accelerator; NA = not
applicable; OARs = organs at risk; PET = positron emission tomography;
PICOTS = population, interventions, comparators, outcomes, timing, and
setting; SABR = stereotactic ablative radiotherapy; SBPT =
stereotactic body proton therapy; SBRT = stereotactic body radiation
therapy; UHF = ultra-hypofractionated radiation therapy; VMAT =
volumetric modulated arc therapy.
\a\ United Nations Development Programme. Human Development Index.
Retrieved from https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025-00547 Filed 1-13-25; 8:45 am]
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