Clinical trial Recruiting at 208 sites Phase 3 Interventional Ages 18 and up Men only

Adding docetaxel to hormonal therapy and apalutamide for metastatic prostate cancer

Official title: Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Run by Alliance for Clinical Trials in Oncology · NCT06931340 · Data updated 2026-11-12

This trial tests whether giving the chemotherapy drug docetaxel in addition to hormone therapy and apalutamide helps men with metastatic castration-sensitive prostate cancer live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment1260 (estimated)
SponsorAlliance for Clinical Trials in Oncology
Academic / other
Drugs / interventionschemotherapy, radiation
Locations214 sites (Tucson, Arizona and 213 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedNovember 11, 2031
Study endsMay 8, 2039
Registry record updatedNovember 3, 2026
Trial IDNCT06931340 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with histologically confirmed metastatic (M1) castration-sensitive prostate adenocarcinoma documented by conventional imaging who are eligible for androgen deprivation therapy, apalutamide, and fit for docetaxel chemotherapy.

Probably not a fit

Patients without metastatic disease, those with small cell histology, only regional pelvic node involvement (N1), or those who cannot tolerate chemotherapy are unlikely to benefit from this trial regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase III trial comparing a triplet regimen (androgen deprivation therapy + apalutamide + docetaxel) versus a doublet regimen (androgen deprivation therapy + apalutamide) in men with metastatic castration-sensitive prostate cancer. The primary endpoint is overall survival, with multiple secondary endpoints including radiographic progression, time to castration-resistant disease, symptomatic skeletal events, PSA responses, and safety by CTCAE v5.0. The trial will also examine outcomes in biomarker-defined subgroups based on tumor suppressor gene alterations (TP53, PTEN, RB1) and stratify by disease volume and timing. Imaging (CT/MRI and bone scan) is used to document metastatic disease and to assess progression per RECIST and PCWG3 criteria.

Why it matters

Potential benefit: If successful, adding docetaxel could extend survival and delay disease progression for men with metastatic castration-sensitive prostate cancer.

How similar studies have gone: Prior trials have shown benefit from adding docetaxel to ADT and from adding androgen receptor inhibitors to ADT, and recent triplet approaches (for example darolutamide or abiraterone combined with ADT and docetaxel) have produced encouraging improvements in outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 it's running

  • Banner University Medical Center - Tucson
    Tucson, Arizona, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona, United States
    Recruiting
  • Kaiser Permanente Dublin
    Dublin, California, United States
    Recruiting
  • Kaiser Permanente-Fremont
    Fremont, California, United States
    Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Fresno, California, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
Show 44 more locations
  • Kaiser Permanente- Modesto MOB II
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente-Modesto
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Eisenhower Medical Center
    Rancho Mirage, California, United States
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California, United States
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-South Sacramento
    Sacramento, California, United States
    Recruiting
  • UC San Diego Medical Center - Hillcrest
    San Diego, California, United States
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, United States
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, United States
    Recruiting
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Vallejo
    Vallejo, California, United States
    Recruiting
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado, United States
    Recruiting
  • Kaiser Permanente-Franklin
    Denver, Colorado, United States
    Recruiting
  • Shaw Cancer Center
    Edwards, Colorado, United States
    Recruiting
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado, United States
    Recruiting
  • Kaiser Permanente-Rock Creek
    Lafayette, Colorado, United States
    Recruiting
  • Kaiser Permanente-Lone Tree
    Lone Tree, Colorado, United States
    Recruiting
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia, United States
    Recruiting
  • Malcom Randall Veterans Administration Medical Center
    Gainesville, Florida, United States
    Recruiting
  • Northside Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Northside Hospital - Duluth
    Duluth, Georgia, United States
    Recruiting
  • Northside Hospital - Gwinnett
    Lawrenceville, Georgia, United States
    Recruiting
  • Kaiser Permanente Moanalua Medical Center
    Honolulu, Hawaii, United States
    Recruiting
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho, United States
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho, United States
    Recruiting
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho, United States
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho, United States
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho, United States
    Recruiting
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois, United States
    Recruiting
  • Illinois CancerCare-Canton
    Canton, Illinois, United States
    Recruiting
  • Illinois CancerCare-Carthage
    Carthage, Illinois, United States
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois, United States
    Recruiting
  • Rush MD Anderson Cancer Center
    Chicago, Illinois, United States
    Recruiting
  • University of Illinois
    Chicago, Illinois, United States
    Recruiting
  • Carle at The Riverfront
    Danville, Illinois, United States
    Recruiting

+164 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.