Supplemental Evidence and Data Request on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY> <SUBJECT>Supplemental Evidence and Data Request on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Agency for Healthcare Research and Quality (AHRQ), HHS. <HD SOURCE="HED">ACTION:</HD> Request for Supplemental Evidence and Data Submission. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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 <E T="03">Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review,</E> 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 Access to published and unpublished pertinent scientific information will improve the quality of this review. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Submission Deadline</E> on or before February 13, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> <E T="03">Email submissions: epc@ahrq.hhs.gov.</E> <E T="03">Print submissions:</E> <E T="03">Mailing Address:</E> Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, <E T="03">Attn:</E> EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. <E T="03">Shipping Address (FedEx, UPS, etc.):</E> Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, <E T="03">Attn:</E> EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Kelly Carper, Telephone: 301-427-1656 or Email: <E T="03">epc@ahrq.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for <E T="03">Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review.</E> 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 T="03">e.g.,</E> details of studies conducted). We are looking for studies that report on <E T="03">Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review.</E> The entire research protocol is available online at: <E T="03"> https://effectivehealthcare.ahrq.gov/products/hypofractionated-radiation-therapy/protocol</E> . This is to notify the public that the EPC Program would find the following information on <E T="03">Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review</E> helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please <E T="03">indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.</E> <E T="03">For completed studies that do not have results on ClinicalTrials.gov,</E> 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. <E T="03">A list of ongoing studies that your organization has sponsored for this topic.</E> 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 <E T="03">ALL Phase II and above clinical trials</E> 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 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: <E T="03">https://effectivehealthcare.ahrq.gov/email-updates.</E> 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. <HD SOURCE="HD1">Key Questions (KQ)</HD> <E T="03">KQ 1:</E> 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? <E T="03">KQ 1a:</E> Do findings vary with respect to patient characteristics ( <E T="03">e.g.,</E> age, race and ethnicity), pretreatment characteristics ( <E T="03">e.g.,</E> risk group, prostate gland volume, lower urinary tract symptoms, prior prostate procedures), treatment targets ( <E T="03">i.e.,</E> prostate with or without treatment of pelvic lymph nodes), and use of adjunctive therapies ( <E T="03">e.g.,</E> with or without neoadjuvant or adjuvant androgen deprivation therapy)? <E T="03">KQ 2:</E> 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? <E T="03">KQ 2a:</E> Do findings vary with respect to patient characteristics ( <E T="03">e.g.,</E> age, race, and ethnicity), pretreatment characteristics ( <E T="03">e.g.,</E> risk group, prostate gland volume, lower urinary tract symptoms, prior prostate procedures), treatment targets ( <E T="03">i.e.,</E> prostate with or without treatment of pelvic lymph nodes), and use of adjunctive therapies ( <E T="03">i.e.,</E> with or without neoadjuvant or adjuvant androgen deprivation therapy)? <E T="03">KQ 3:</E> 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? <E T="03">KQ 3a:</E> Do findings vary with respect to pretreatment characteristics ( <E T="03">i.e.,</E> tumor stage, disease risk, urinary tract symptoms, prior prostate procedures)? <E T="03">KQ 4:</E> 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 ( <E T="03">i.e.,</E> prostate alone, prostate with seminal vesicles, prostate with seminal vesicles and pelvic lymph nodes; with or without focal intraprostatic boosts)? <FP SOURCE="FP1-2"> <E T="03">KQ 4a:</E> Do findings vary with respect to pretreatment characteristics ( <E T="03">i.e.,</E> imaging)? </FP> <FP SOURCE="FP1-2"> <E T="03">KQ 5:</E> 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? </FP> <HD SOURCE="HD2">Contextual Question</HD> Does the utilization of fractionation schedule ( <E T="03">i.e.,</E> conventional fractionation, moderate hypofractionation, and ultra-hypofractionation) differ by factors such as age, race, ethnicity, socioeconomic status, or geography? <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s20,r100,r30"> <TTITLE>PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)</TTITLE> <CHED H="1"> </CHED> <CHED H="1">Inclusion criteria</CHED> <CHED H="1">Exclusion criteria</CHED> <ROW EXPSTB="02" RUL="s"> <ENT I="22"> <E T="02">Preliminary PICOTS criteria</E> </ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">Population</ENT> <ENT> 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 T="03">e.g.,</E> age, race and ethnicity), pretreatment characteristics ( <E T="03">e.g.,</E> prostate cancer risk group, prostate gland volume, presence of lower urinary tract symptoms), use of adjunctive therapies ( <E T="03">e.g.,</E> androgen deprivation therapy) </ENT> <ENT>Individuals aged <18 years, those with non-localized stage of prostate cancer at enrollment.</ENT> </ROW> <ROW> <ENT I="01">Interventions</ENT> <ENT> 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 T="03">e.g.,</E> prostate, seminal, vesicles, pelvic lymph nodes, focal intraprostatic boosts). KQ 5. 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