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Taking people in United StatesPhase 3

Tests adding docetaxel chemotherapy to hormone therapy and apalutamide for metastatic prostate cancer

Tests adding docetaxel chemotherapy to hormone therapy and apalutamide in men with spread prostate cancer.

Key facts

Who runs it
Alliance for Clinical Trials in Oncology
Where
Ames, Anaconda, Antigo, Appleton, Atlanta, Aurora, Basking Ridge, Bemidji, Berlin Corners, Billings, Bismarck, Bloomington, Boise, Boone, Bozeman, Brighton, Brookfield, Buffalo, Burlington, Canton, Cape Girardeau, Carthage, Cedar Rapids, Centralia, Charleston, Chelsea, Cherry Hill, Chicago, Chilton, City of Saint Peters, Coeur d'Alene, Columbus, Commack, Cortland, Creve Coeur, Dallas, Danville, Decatur, Denver, Dixon, Dover, Dublin, Duluth, Durham, Edwards, Effingham, Erie, Escanaba, Eureka, Fargo, Flint, Fort Dodge, Fort Worth, Franklin, Fredericksburg, Fremont, Fresno, Fruitland, Gainesville, Galesburg, Grand Junction, Great Falls, Green Bay, Greenville, Greenwood, Harrison, Hays, Hines, Honolulu, Jefferson, Jefferson Hills, Kalispell, Kansas City, Kewanee, La Jolla, Lafayette, Lansing, Lawrence, Lawrenceville, Lee's Summit, Livonia, Lone Tree, Macomb, Madison, Marshalltown, Mattoon, Medford, Menomonee Falls, Mequon, Meridian, Middletown, Milford, Milwaukee, Missoula, Modesto, Monroeville, Montvale, Mount Vernon, Murray, Nampa, Natrona Heights, New Berlin, New York, Normal, O'Fallon, Oak Creek, Oakland, Oconto Falls, Ogden, Oklahoma City, Olathe, Oshkosh, Ottawa, Overland Park, Pekin, Peoria, Peru, Philadelphia, Pinehurst, Pittsburgh, Pontiac, Post Falls, Princeton, Racine, Rancho Mirage, Rapid City, Rhinelander, Richardson, Richmond, Roseville, Sacramento, Saint Cloud, Salina, Salt Lake City, San Diego, San Francisco, San Jose, San Leandro, San Rafael, Sandpoint, Sandy City, Santa Clara, Santa Rosa, Sayre, Sewell, Sheboygan, Shiloh, Sioux Falls, South San Francisco, Springfield, St Louis, St. George, Stevens Point, Stony Brook, Sturgeon Bay, Sylvania, Tappahannock, Topeka, Tucson, Uniondale, Urbana, Vallejo, Walnut Creek, Washington, Washington D.C., Wausau, Wauwatosa, West Bend, Westwood, Wexford, Willow Grove, Wisconsin Rapids, and Ypsilanti, United StatesSee the 214 sites
Trial code
Registry title
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Status
Recruiting
Phase
Phase 3
People taking part
1,260 people, planned
Started
1 Dec 2025
Expected to end
8 May 2039
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Androgen Therapy
  • Apalutamide
  • Docetaxel
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Bone Scan
  • PSMA PET Scan
  • Biospecimen Collection
  • Questionnaire Administration
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has spread to other parts of the body and who are still sensitive to hormone therapy. It tests adding docetaxel to hormonal therapy and apalutamide.

Age
18 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma (no small cell type) that has spread, seen on CT, MRI and/or bone scan. Disease seen only on PSMA-PET does not count. No low-volume recurrence after earlier treatment of the prostate (4 or fewer bone metastases and no visceral metastasis). Spread only to nearby lymph nodes below the aortic bifurcation does not count.
Earlier treatment
Hormone therapy (ADT), with or without an anti-androgen or ARSI, within 120 days before joining is allowed. No earlier chemotherapy for prostate cancer.
Biomarker or test result
Next generation sequencing (NGS) results from a tissue test must be available when joining. Failed NGS testing means the person cannot join.

Main reasons for not taking part

  • Prior chemotherapy for prostate cancer
  • Failed NGS testing
  • Seizure or a condition that may lead to seizures
  • Uncontrolled high blood pressure (160 or higher systolic, or 100 or higher diastolic)
  • Regular use of strong CYP3A4 inhibitors or inducers

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Documentation of disease:; Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
  • Must have had evidence of metastatic disease (American Joint Committee on Cancer [AJCC] metastasis [M]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:; Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR; Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes [N]1, below the aortic bifurcation) will not be eligible for the study; OR; Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm; Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria
  • No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)
  • Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible
  • Prior treatment; ADT (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration; No prior chemotherapy for prostate cancer
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate transaminase [SGT]) ≤ 1.5 x upper limit of normal (ULN)
  • Calculated (Calc.) creatinine clearance > 30 mL/min
  • Serum potassium ≥ 3.5 mmol/L
  • Comorbid conditions; Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial; Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression; HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial; Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; Hepatitis C: 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; No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy); Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible; Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >= 160 mmHg or diastolic BP >= 100 mmHg despite medical management are not permitted to register; Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register
  • Concomitant medications; Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information; Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment; Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information
  • Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Where in United States

  • Mary Greeley Medical CenterAmes, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • McFarland Clinic - AmesAmes, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • Community Hospital of AnacondaAnaconda, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Aspirus Cancer Care-Antigo-Volm Cancer CenterAntigo, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-AppletonAppleton, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • ThedaCare Regional Cancer CenterAppleton, United StatesContact: Joyce Philip (principal investigator)Taking people
  • Northside HospitalAtlanta, United StatesContact: Shailesh R. Satpute (principal investigator)Taking people
  • Rocky Mountain Regional VA Medical CenterAurora, United StatesContact: Jessica D. McDermott (principal investigator)Taking people
  • Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • Sanford Joe Lueken Cancer CenterBemidji, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Central Vermont Medical Center/National Life Cancer TreatmentBerlin Corners, United StatesContact: Rahul Anil (principal investigator)Taking people
  • Billings Clinic Cancer CenterBillings, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Saint Vincent Frontier Cancer CenterBillings, United StatesContact: Wallace Jones (principal investigator)Taking people
  • Sanford Bismarck Medical CenterBismarck, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Illinois CancerCare-BloomingtonBloomington, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Saint Luke's Cancer Institute - BoiseBoise, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • McFarland Clinic - BooneBoone, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Bozeman Health Deaconess HospitalBozeman, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-BrookfieldBrookfield, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Roswell Park Cancer InstituteBuffalo, United StatesContact: Ellis G. Levine (principal investigator)Taking people
  • University of Vermont and State Agricultural CollegeBurlington, United StatesContact: Rahul Anil (principal investigator)Taking people
  • University of Vermont Medical CenterBurlington, United StatesContact: Rahul Anil (principal investigator)Taking people
  • Aultman Health FoundationCanton, United StatesContact: Mehool A. Patel (principal investigator)Taking people
  • Illinois CancerCare-CantonCanton, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Saint Francis Medical CenterCape Girardeau, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Illinois CancerCare-CarthageCarthage, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Mercy HospitalCedar Rapids, United StatesContact: Deborah W. Wilbur (principal investigator)Taking people
  • Oncology Associates at Mercy Medical CenterCedar Rapids, United StatesContact: Deborah W. Wilbur (principal investigator)Taking people
  • Centralia Oncology ClinicCentralia, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Vandalia Health/CAMC Institute for Academic MedicineCharleston, United StatesContact: Kok Hoe Chan (principal investigator)Taking people
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Jefferson Cherry Hill HospitalCherry Hill, United StatesContact: Kevin K. Zarrabi (principal investigator)Taking people
  • Rush MD Anderson Cancer CenterChicago, United StatesContact: Manan Shah (principal investigator)Taking people
  • University of IllinoisChicago, United StatesContact: Karine Tawagi (principal investigator)Taking people
  • Ascension Calumet Hospital-ChiltonChilton, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Ohio State University Comprehensive Cancer CenterColumbus, United StatesContact: Lingbin Meng (principal investigator)Taking people
  • Memorial Sloan Kettering CommackCommack, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • Guthrie Cortland Memorial HospitalCortland, United StatesContact: Alina Basnet (principal investigator)Taking people
  • Siteman Cancer Center at West County HospitalCreve Coeur, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • UT Southwestern Simmons Cancer Center - RedBirdDallas, United StatesContact: Qian Qin (principal investigator)Taking people
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesContact: Qian Qin (principal investigator)Taking people
  • Carle at The RiverfrontDanville, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Cancer Care Specialists of Illinois - DecaturDecatur, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Decatur Memorial HospitalDecatur, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Kaiser Permanente-FranklinDenver, United StatesContact: Matthew J. Eadens (principal investigator)Taking people
  • Illinois CancerCare-DixonDixon, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Bayhealth Hospital Kent CampusDover, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Kaiser Permanente DublinDublin, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Northside Hospital - DuluthDuluth, United StatesContact: Shailesh R. Satpute (principal investigator)Taking people
  • Duke University Medical CenterDurham, United StatesContact: Hannah D. McManus (principal investigator)Taking people
  • Durham VA Medical CenterDurham, United StatesContact: Rhonda L. Bitting (principal investigator)Taking people
  • Shaw Cancer CenterEdwards, United StatesContact: Erin Schwab (principal investigator)Taking people
  • Carle Physician Group-EffinghamEffingham, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Crossroads Cancer CenterEffingham, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Saint Vincent HospitalErie, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • OSF Saint Francis Hospital and Medical GroupEscanaba, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • Illinois CancerCare-EurekaEureka, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Sanford Broadway Medical CenterFargo, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Sanford Roger Maris Cancer CenterFargo, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Cancer Hematology Centers - FlintFlint, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Genesys Hurley Cancer InstituteFlint, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Hurley Medical CenterFlint, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesContact: Qian Qin (principal investigator)Taking people
  • Reiman Cancer Center-Ascension Wisconsin Health Center-RawsonFranklin, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Hematology Oncology Associates of Fredericksburg IncFredericksburg, United StatesContact: Asit K. Paul (principal investigator)Taking people
  • Kaiser Permanente-FremontFremont, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente Fresno Orchard PlazaFresno, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Saint Luke's Cancer Institute - FruitlandFruitland, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Malcom Randall Veterans Administration Medical CenterGainesville, United StatesContact: Jess DeLaune (principal investigator)Taking people
  • Illinois CancerCare-GalesburgGalesburg, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Saint Mary's Hospital and Regional Medical CenterGrand Junction, United StatesContact: Wallace Jones (principal investigator)Taking people
  • Benefis Sletten Cancer InstituteGreat Falls, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • Saint Francis Cancer CenterGreenville, United StatesContact: Stephen H. Dyar (principal investigator)Taking people
  • Saint Francis HospitalGreenville, United StatesContact: Stephen H. Dyar (principal investigator)Taking people
  • Self Regional HealthcareGreenwood, United StatesContact: Albert C. Lockhart (principal investigator)Taking people
  • Memorial Sloan Kettering WestchesterHarrison, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • HaysMedHays, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Edward Hines Jr VA HospitalHines, United StatesContact: Elizabeth Henry (principal investigator)Taking people
  • Kaiser Permanente Moanalua Medical CenterHonolulu, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • McFarland Clinic - JeffersonJefferson, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Jefferson HospitalJefferson Hills, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • Logan Health Medical CenterKalispell, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • University Health Truman Medical CenterKansas City, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • University of Kansas Cancer Center - BriarcliffKansas City, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • University of Kansas Cancer Center - NorthKansas City, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Illinois CancerCare-Kewanee ClinicKewanee, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesContact: Yu-Wei Chen (principal investigator)Taking people
  • Kaiser Permanente-Rock CreekLafayette, United StatesContact: Matthew J. Eadens (principal investigator)Taking people
  • University of Michigan Health - Sparrow LansingLansing, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Lawrence Memorial HospitalLawrence, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Northside Hospital - GwinnettLawrenceville, United StatesContact: Shailesh R. Satpute (principal investigator)Taking people
  • University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Kaiser Permanente-Lone TreeLone Tree, United StatesContact: Matthew J. Eadens (principal investigator)Taking people
  • Illinois CancerCare-MacombMacomb, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • William S Middleton VA Medical CenterMadison, United StatesContact: David Kosoff (principal investigator)Taking people
  • McFarland Clinic - MarshalltownMarshalltown, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • Carle Physician Group-Mattoon/CharlestonMattoon, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Aspirus Medford HospitalMedford, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • Froedtert Menomonee Falls HospitalMenomonee Falls, United StatesContact: Deepak Kilari (principal investigator)Taking people
  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-MequonMequon, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Saint Luke's Cancer Institute - MeridianMeridian, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Memorial Sloan Kettering MonmouthMiddletown, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • Bayhealth Hospital Sussex CampusMilford, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Ascension Columbia Saint Mary's Hospital-Milwaukee CampusMilwaukee, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Medical College of WisconsinMilwaukee, United StatesContact: Deepak Kilari (principal investigator)Taking people
  • Zablocki Veterans Administration Medical CenterMilwaukee, United StatesContact: Sumana Devata (principal investigator)Taking people
  • Community Medical CenterMissoula, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Kaiser Permanente- Modesto MOB IIModesto, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente-ModestoModesto, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Forbes HospitalMonroeville, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • Memorial Sloan Kettering BergenMontvale, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • SSM Health Good SamaritanMount Vernon, United StatesContact: Jay W. Carlson (principal investigator)Taking people
  • Intermountain Medical CenterMurray, United StatesContact: Wallace Jones (principal investigator)Taking people
  • Saint Luke's Cancer Institute - NampaNampa, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Allegheny Valley HospitalNatrona Heights, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • Froedtert and MCW Moorland Reserve Health CenterNew Berlin, United StatesContact: Deepak Kilari (principal investigator)Taking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • Mount Sinai HospitalNew York, United StatesContact: Eric J. Miller (principal investigator)Taking people
  • Carle BroMenn Medical CenterNormal, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Carle Cancer Institute NormalNormal, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Cancer Care Center of O'FallonO'Fallon, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • HSHS Saint Elizabeth's HospitalO'Fallon, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Drexel Town Square Health CenterOak Creek, United StatesContact: Deepak Kilari (principal investigator)Taking people
  • Kaiser Permanente-OaklandOakland, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Saint Vincent Hospital Cancer Center at Oconto FallsOconto Falls, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • McKay-Dee Hospital CenterOgden, United StatesContact: Wallace Jones (principal investigator)Taking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Adanma Anji Ayanambakkam Attanathi (principal investigator)Taking people
  • The University of Kansas Cancer Center - OlatheOlathe, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Ascension Northeast Wisconsin-Mercy Hospital-OshkoshOshkosh, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Illinois CancerCare-Ottawa ClinicOttawa, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • University of Kansas Cancer Center-Overland ParkOverland Park, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Illinois CancerCare-PekinPekin, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Illinois CancerCare-PeoriaPeoria, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Illinois CancerCare-PeruPeru, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Jefferson Torresdale HospitalPhiladelphia, United StatesContact: Kevin K. Zarrabi (principal investigator)Taking people
  • Thomas Jefferson University HospitalPhiladelphia, United StatesContact: Kevin K. Zarrabi (principal investigator)Taking people
  • Jefferson Methodist HospitalPhiladelphia, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • FirstHealth of the Carolinas-Moore Regional HospitalPinehurst, United StatesContact: Charles S. Kuzma (principal investigator)Taking people
  • Allegheny General HospitalPittsburgh, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • West Penn HospitalPittsburgh, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Illinois CancerCare-PrincetonPrinceton, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Ascension All Saints Hospital-Spring Street-RacineRacine, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Eisenhower Medical CenterRancho Mirage, United StatesContact: Delshad Ahmad (principal investigator)Taking people
  • Rapid City Regional HospitalRapid City, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Aspirus Cancer Care-Rhinelander-James Beck Cancer CenterRhinelander, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesContact: Qian Qin (principal investigator)Taking people
  • VCU Massey Cancer Center at Stony PointRichmond, United StatesContact: Asit K. Paul (principal investigator)Taking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: Asit K. Paul (principal investigator)Taking people
  • Kaiser Permanente-RosevilleRoseville, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente Downtown CommonsSacramento, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente-South SacramentoSacramento, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesContact: Donald J. Jurgens (principal investigator)Taking people
  • Salina Regional Health CenterSalina, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • LDS HospitalSalt Lake City, United StatesContact: Wallace Jones (principal investigator)Taking people
  • UC San Diego Medical Center - HillcrestSan Diego, United StatesContact: Yu-Wei Chen (principal investigator)Taking people
  • Kaiser Permanente-San FranciscoSan Francisco, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente-Santa Teresa-San JoseSan Jose, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente San LeandroSan Leandro, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser San Rafael-GallinasSan Rafael, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Intermountain Health Alta View HospitalSandy City, United StatesContact: Wallace Jones (principal investigator)Taking people
  • Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente-Santa RosaSanta Rosa, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Guthrie Medical Group PC-Robert Packer HospitalSayre, United StatesContact: Joyson Poulose (principal investigator)Taking people
  • Sidney Kimmel Cancer Center Washington TownshipSewell, United StatesContact: Kevin K. Zarrabi (principal investigator)Taking people
  • Saint Vincent Hospital Cancer Center at SheboyganSheboygan, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • Sheboygan Physicians GroupSheboygan, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • Memorial Hospital EastShiloh, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Sanford Cancer Center Oncology ClinicSioux Falls, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Kaiser Permanente-South San FranciscoSouth San Francisco, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Southern Illinois University School of MedicineSpringfield, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Springfield ClinicSpringfield, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Springfield Memorial HospitalSpringfield, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Mercy Hospital Saint LouisSt Louis, United StatesContact: Jay W. Carlson (principal investigator)Taking people
  • Mercy Hospital SouthSt Louis, United StatesContact: Jay W. Carlson (principal investigator)Taking people
  • Siteman Cancer Center at Christian HospitalSt Louis, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Siteman Cancer Center-South CountySt Louis, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Veteran's Affairs Medical Center - Saint LouisSt Louis, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Washington University School of MedicineSt Louis, United StatesContact: Eric M. Knoche (principal investigator)Taking people
  • Saint George Regional Medical CenterSt. George, United StatesContact: Wallace Jones (principal investigator)Taking people
  • Aspirus Cancer Care - Stevens PointStevens Point, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • Stony Brook University Medical CenterStony Brook, United StatesContact: Judy Huang (principal investigator)Taking people
  • Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesContact: Anthony J. Jaslowski (principal investigator)Taking people
  • ProMedica Flower HospitalSylvania, United StatesContact: Jeffrey H. Muler (principal investigator)Taking people
  • VCU Health Tappahannock HospitalTappahannock, United StatesContact: Asit K. Paul (principal investigator)Taking people
  • University of Kansas Health System Saint Francis CampusTopeka, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Banner University Medical Center - TucsonTucson, United StatesContact: Edward P. Gelmann (principal investigator)Taking people
  • University of Arizona Cancer Center-North CampusTucson, United StatesContact: Edward P. Gelmann (principal investigator)Taking people
  • Memorial Sloan Kettering NassauUniondale, United StatesContact: Kristine P. Lacuna (principal investigator)Taking people
  • Carle Cancer CenterUrbana, United StatesContact: Kendrith M. Rowland (principal investigator)Taking people
  • Kaiser Permanente-VallejoVallejo, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Kaiser Permanente-Walnut CreekWalnut Creek, United StatesContact: Andrea L. Harzstark (principal investigator)Taking people
  • Illinois CancerCare - WashingtonWashington, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesContact: Suthee Rapisuwon (principal investigator)Taking people
  • MedStar Washington Hospital CenterWashington D.C., United StatesContact: Suthee Rapisuwon (principal investigator)Taking people
  • Aspirus Cancer Care-WausauWausau, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • Ascension Southeast Wisconsin Hospital-Mayfair Road-WauwatosaWauwatosa, United StatesContact: Kamal Kant Singh Abbi (principal investigator)Taking people
  • Froedtert West Bend Hospital/Kraemer Cancer CenterWest Bend, United StatesContact: Deepak Kilari (principal investigator)Taking people
  • University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesContact: Elizabeth M. Wulff (principal investigator)Taking people
  • Wexford Health and Wellness PavilionWexford, United StatesContact: Shifeng S. Mao (principal investigator)Taking people
  • Asplundh Cancer PavilionWillow Grove, United StatesContact: Kevin K. Zarrabi (principal investigator)Taking people
  • Aspirus Cancer Care - Wisconsin RapidsWisconsin Rapids, United StatesContact: Andrew J. Huang (principal investigator)Taking people
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesContact: Christopher M. Reynolds (principal investigator)Taking people

About the trial

What the trial wants to find out

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide 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. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

The 2 groups in the trial

  • Arm 1 (ADT, apalutamide)Existing treatment, for comparison

    Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

    Treatment: Androgen Therapy, Apalutamide, Computed Tomography, Magnetic Resonance Imaging, Bone Scan, PSMA PET Scan, Biospecimen Collection, and Questionnaire Administration

  • Arm 2 (ADT, apalutamide, docetaxel)Treatment being tested

    Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

    Treatment: Androgen Therapy, Apalutamide, Docetaxel, Computed Tomography, Magnetic Resonance Imaging, Bone Scan, PSMA PET Scan, Biospecimen Collection, and Questionnaire Administration

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)
Plain-language title
Tests adding docetaxel chemotherapy to hormone therapy and apalutamide for metastatic prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026