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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: 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: 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/​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: 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.* *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. *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. 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 
                    ( print 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)
Inclusion criteria
Exclusion criteria**Preliminary PICOTS criteria**Population
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)
Individuals aged <18 years, those with non-localized stage of prostate cancer at enrollment.Interventions
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, 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).
Other treatments and techniques. Salvage radiation therapy; adjuvant or neoadjuvant radiation therapy.Comparators
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
Other comparators.Outcomes
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
Other outcomes.Timing
Any followup duration
NA( print page 3220)Setting
KQ 1—KQ 5. All clinical settings
NAStudy Design
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
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-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