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NCT06632977Toboroz2. fázis

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Állapot (regiszter)
Toboroz
Fázis (regiszter)
2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
474 (tervezett)
Első benyújtás
2024. okt. 1.
Kezdés
2025. febr. 6.
Elsődleges befejezés
2030. ápr. 11.
Fő szponzor
Alliance for Clinical Trials in Oncology
Betegségek
Prosztatarák
NCT-szám
NCT06632977

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2. fázis
  • Tervezett résztvevők: 474
  • 2025. febr. 6. és az elsődleges befejezés (2030. ápr. 11.) között
  • 108 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Kiket keres a vizsgálat

  • PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
  • PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
  • PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
  • PRE-REGISTRATION: Age ≥ 18 years.
  • REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply): * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy. * Radiographic progression per RECIST 1.1 criteria for soft tissue lesions * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  • REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
  • REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
  • REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
  • REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
  • REGISTRATION: No major surgery within 4 weeks of registration.
  • REGISTRATION: No prior treatment with EZH inhibitors.
  • REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
  • REGISTRATION: None of the following conditions: * Current use of moderate or strong cytochrome P450 (CYP)3A inducers. * Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG. * Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg). * Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy. * Moderate to severe hepatic impairment (Child-Pugh Class C)
  • REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
  • REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
  • REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • REGISTRATION: No bleeding diathesis.
  • REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
  • REGISTRATION: Hemoglobin ≥ 9 g/dL.
  • REGISTRATION: Platelet count ≥ 100,000/mcL.
  • REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal [ULN] for subjects with documented Gilbert\'s disease).
  • REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
  • REGISTRATION: Albumin ≥ 2.8 g/dL.
  • REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to.
  • RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
  • RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
  • RE-REGISTRATION: None of the following conditions: * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
  • RE-REGISTRATION: ECOG Performance Status 0-2.
  • RE-REGISTRATION: No GCSF within 2 weeks of registration.
  • RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
  • RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • RE-REGISTRATION: WBC ≥ 2,500/mcL.
  • RE-REGISTRATION: ANC ≥ 1,500/mcL.
  • RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
  • RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
  • RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
  • RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
  • RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
  • RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
  • RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to. Exclusion Criteria: -

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (108)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
McFarland Clinic - AmesAmesEgyesült ÁllamokToboroz
University of Iowa Healthcare Cancer Services Quad CitiesBettendorfEgyesült ÁllamokToboroz
Billings Clinic Cancer CenterBillingsEgyesült ÁllamokToboroz
University of Alabama at Birmingham Cancer CenterBirminghamEgyesült ÁllamokToboroz
Illinois CancerCare-BloomingtonBloomingtonEgyesült ÁllamokToboroz
Dana-Farber Cancer InstituteBostonEgyesült ÁllamokFelfüggesztve
Essentia Health Saint Joseph's Medical CenterBrainerdEgyesült ÁllamokToboroz
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrightonEgyesült ÁllamokToboroz
Roswell Park Cancer InstituteBuffaloEgyesült ÁllamokToboroz
Trinity Health IHA Medical Group Hematology Oncology - CantonCantonEgyesült ÁllamokToboroz
Illinois CancerCare-CantonCantonEgyesült ÁllamokToboroz
UNC Lineberger Comprehensive Cancer CenterChapel HillEgyesült ÁllamokToboroz
Vandalia Health/CAMC Institute for Academic MedicineCharlestonEgyesült ÁllamokFut, nem toboroz
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelseaEgyesült ÁllamokToboroz
Enloe Medical CenterChicoEgyesült ÁllamokToboroz
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersEgyesült ÁllamokToboroz
MetroHealth Medical CenterClevelandEgyesült ÁllamokToboroz
Kootenai Health - Coeur d'AleneCoeur d'AleneEgyesült ÁllamokFelfüggesztve
Memorial Hospital NorthColorado SpringsEgyesült ÁllamokToboroz
UCHealth Memorial Hospital CentralColorado SpringsEgyesült ÁllamokToboroz
MU Health - University Hospital/Ellis Fischel Cancer CenterColumbiaEgyesült ÁllamokFut, nem toboroz
Ohio State University Comprehensive Cancer CenterColumbusEgyesült ÁllamokToboroz
Siteman Cancer Center at West County HospitalCreve CoeurEgyesült ÁllamokToboroz
UT Southwestern Simmons Cancer Center - RedBirdDallasEgyesült ÁllamokToboroz
Parkland Memorial HospitalDallasEgyesült ÁllamokFelfüggesztve
UT Southwestern/Simmons Cancer Center-DallasDallasEgyesült ÁllamokToboroz
Carle at The RiverfrontDanvilleEgyesült ÁllamokToboroz
Essentia Health Cancer CenterDuluthEgyesült ÁllamokToboroz
Saint Elizabeth Healthcare EdgewoodEdgewoodEgyesült ÁllamokToboroz
Swedish Cancer Institute-EdmondsEdmondsEgyesült ÁllamokToboroz
Carle Physician Group-EffinghamEffinghamEgyesült ÁllamokToboroz
UC San Diego Health System - EncinitasEncinitasEgyesült ÁllamokToboroz
Illinois CancerCare-EurekaEurekaEgyesült ÁllamokToboroz
Essentia Health Cancer Center-South University ClinicFargoEgyesült ÁllamokToboroz
Poudre Valley HospitalFort CollinsEgyesült ÁllamokToboroz
Cancer Care and Hematology-Fort CollinsFort CollinsEgyesült ÁllamokToboroz
Saint Elizabeth Healthcare Fort ThomasFort ThomasEgyesült ÁllamokFelfüggesztve
UT Southwestern/Simmons Cancer Center-Fort WorthFort WorthEgyesült ÁllamokToboroz
Dana-Farber Cancer Institute at FoxboroughFoxboroughEgyesült ÁllamokToboroz
Gibbs Cancer Center-GaffneyGaffneyEgyesült ÁllamokToboroz
UCHealth Greeley HospitalGreeleyEgyesült ÁllamokToboroz
Gibbs Cancer Center-PelhamGreerEgyesült ÁllamokToboroz
Hackensack University Medical CenterHackensackEgyesült ÁllamokToboroz
Tripler Army Medical CenterHonoluluEgyesült ÁllamokToboroz
Edwards Comprehensive Cancer CenterHuntingtonEgyesült ÁllamokToboroz
University of Iowa/Holden Comprehensive Cancer CenterIowa CityEgyesült ÁllamokToboroz
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineEgyesült ÁllamokFut, nem toboroz
Jupiter Medical CenterJupiterEgyesült ÁllamokToboroz
University of Kansas Cancer CenterKansas CityEgyesült ÁllamokToboroz
UC San Diego Moores Cancer CenterLa JollaEgyesült ÁllamokToboroz
University of Michigan Health - Sparrow LansingLansingEgyesült ÁllamokToboroz
Trinity Health Saint Mary Mercy Livonia HospitalLivoniaEgyesült ÁllamokToboroz
Medical Center of the RockiesLovelandEgyesült ÁllamokToboroz
Marshfield Medical Center-MarshfieldMarshfieldEgyesült ÁllamokToboroz
Carle Physician Group-Mattoon/CharlestonMattoonEgyesült ÁllamokToboroz
Bon Secours Memorial Regional Medical CenterMechanicsvilleEgyesült ÁllamokToboroz
Froedtert Menomonee Falls HospitalMenomonee FallsEgyesült ÁllamokToboroz
Dana Farber-Merrimack ValleyMethuenEgyesült ÁllamokToboroz
Bon Secours Saint Francis Medical CenterMidlothianEgyesült ÁllamokToboroz
Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalMilfordEgyesült ÁllamokToboroz
Beebe South Coastal Health CampusMillvilleEgyesült ÁllamokToboroz
Medical College of WisconsinMilwaukeeEgyesült ÁllamokToboroz
Vanderbilt University/Ingram Cancer CenterNashvilleEgyesült ÁllamokFelfüggesztve
Medical Oncology Hematology Consultants PANewarkEgyesült ÁllamokToboroz
Helen F Graham Cancer CenterNewarkEgyesült ÁllamokToboroz
Mount Sinai HospitalNew YorkEgyesült ÁllamokToboroz
Drexel Town Square Health CenterOak CreekEgyesült ÁllamokToboroz
Cancer Care Center of O'FallonO'FallonEgyesült ÁllamokToboroz
University of Oklahoma Health Sciences CenterOklahoma CityEgyesült ÁllamokToboroz
The University of Kansas Cancer Center - OlatheOlatheEgyesült ÁllamokToboroz
UC Irvine Health- Chao Family Comprehensive Cancer CenterOrangeEgyesült ÁllamokFut, nem toboroz
Illinois CancerCare-Ottawa ClinicOttawaEgyesült ÁllamokToboroz
University of Kansas Hospital-Indian Creek CampusOverland ParkEgyesült ÁllamokToboroz
Illinois CancerCare-PekinPekinEgyesült ÁllamokToboroz
Illinois CancerCare-PeoriaPeoriaEgyesült ÁllamokToboroz
Illinois CancerCare-PeruPeruEgyesült ÁllamokToboroz
Providence Saint Vincent Medical CenterPortlandEgyesült ÁllamokToboroz
Providence Portland Medical CenterPortlandEgyesült ÁllamokToboroz
Oregon Health and Science UniversityPortlandEgyesült ÁllamokToboroz
Beebe Health CampusRehoboth BeachEgyesült ÁllamokToboroz
UT Southwestern Clinical Center at Richardson/PlanoRichardsonEgyesült ÁllamokToboroz
VCU Massey Comprehensive Cancer CenterRichmondEgyesült ÁllamokToboroz
Bon Secours Richmond Community HospitalRichmondEgyesült ÁllamokToboroz
Bon Secours Cancer Institute at Reynolds CrossingRichmondEgyesült ÁllamokToboroz
VCU Massey Cancer Center at Stony PointRichmondEgyesült ÁllamokToboroz
Bon Secours Saint Mary's HospitalRichmondEgyesült ÁllamokToboroz
University of California Davis Comprehensive Cancer CenterSacramentoEgyesült ÁllamokToboroz
Coborn Cancer Center at Saint Cloud HospitalSaint CloudEgyesült ÁllamokToboroz
UC San Diego Medical Center - HillcrestSan DiegoEgyesült ÁllamokToboroz
Guthrie Medical Group PC-Robert Packer HospitalSayreEgyesült ÁllamokFut, nem toboroz
Swedish Medical Center-First HillSeattleEgyesült ÁllamokToboroz
Memorial Hospital EastShilohEgyesült ÁllamokToboroz
Dana-Farber/Brigham and Women's Cancer Center at South ShoreSouth WeymouthEgyesült ÁllamokToboroz
Spartanburg Medical CenterSpartanburgEgyesült ÁllamokToboroz
Baystate Medical CenterSpringfieldEgyesült ÁllamokToboroz
Stamford Hospital/Bennett Cancer CenterStamfordEgyesült ÁllamokToboroz
Washington University School of MedicineSt LouisEgyesült ÁllamokToboroz
Siteman Cancer Center at Christian HospitalSt LouisEgyesült ÁllamokToboroz
Siteman Cancer Center-South CountySt LouisEgyesült ÁllamokToboroz
University of Kansas Health System Saint Francis CampusTopekaEgyesült ÁllamokToboroz
Banner University Medical Center - TucsonTucsonEgyesült ÁllamokToboroz
University of Arizona Cancer Center-North CampusTucsonEgyesült ÁllamokToboroz
SMC Center for Hematology Oncology UnionUnionEgyesült ÁllamokToboroz
Carle Cancer CenterUrbanaEgyesült ÁllamokToboroz
Illinois CancerCare - WashingtonWashingtonEgyesült ÁllamokToboroz
Froedtert West Bend Hospital/Kraemer Cancer CenterWest BendEgyesült ÁllamokToboroz
University of Kansas Hospital-Westwood Cancer CenterWestwoodEgyesült ÁllamokToboroz
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilantiEgyesült ÁllamokToboroz

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