Notice2025-00547
Supplemental Evidence and Data Request on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review
Primary source
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Published
January 14, 2025
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
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<title>Federal Register, Volume 90 Issue 8 (Tuesday, January 14, 2025)</title>
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[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3218-3220]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00547]
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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.
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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unpublished pertinent scientific information will improve the quality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: <a href="/cdn-cgi/l/email-protection#7c190c1f3c1d140e0d5214140f521b130a"><span class="__cf_email__" data-cfemail="a0c5d0c3e0c1c8d2d18ec8c8d38ec7cfd6">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#9df8edfeddfcf5efecb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="1075607350717862613e7878633e777f66">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/hypofractionated-radiation-therapy/protocol">https://effectivehealthcare.ahrq.gov/products/hypofractionated-radiation-therapy/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
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
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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..
<bullet> Advanced
imaging for target
delineation (any
pretreatment imaging,
i.e., CT, MRI, MR-
linac, PET, urethral
contrast)..
<bullet> Dose-volume
criteria for OARs
(urethra)..
<bullet> Image-
guidance techniques
(i.e., cone-beam CT,
intraprostatic
fiducial markers,
MRI, electromagnetic
tracking)..
<bullet> Delivery
techniques (i.e.,
IMRT, VMAT [term
ARCS] protons [IMPT,
passive scatter],
SBPT, SBRT/SABR, 3D
CRT)..
<bullet> Rectal-
sparing technologies
(e.g., rectal
spacers)..
<bullet> Online
adaptive radiotherapy
(treatment planning
software)..
<bullet> 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 <a href="https://hdr.undp.org/data-center/human-development-index#/indicies/HDI">https://hdr.undp.org/data-center/human-development-index#/indicies/HDI</a>.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025-00547 Filed 1-13-25; 8:45 am]
BILLING CODE 4160-90-P
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