`[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unpublished pertinent scientific information will improve the quality 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]
BILLING CODE 4160-90-P`