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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1260 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 214 sites (Tucson, Arizona and 213 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | November 11, 2031 |
| Study ends | May 8, 2039 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT06931340 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
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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
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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
- Study coordinator: Shiva Baghaie, MPH
- Email: GUprotocols@alliancenctn.org
- Phone: (773) 702-9171
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining talazoparib with hormone therapy and abiraterone for prostate cancer treatment
This study is testing if adding a new drug called talazoparib to standard hormone therapy and abiraterone can help men with advanced prostate cancer do better with their treatment.
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PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
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Testing Different Dosing Schedules of Lutetium-177Lu PSMA RLT in Advanced Prostate Cancer
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Combining ruxolitinib and enzalutamide for advanced prostate cancer treatment
This study is testing if combining two medications, ruxolitinib and enzalutamide, can safely help men with advanced prostate cancer that hasn't responded to hormone therapy.
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Using PET scans to guide radiation therapy for metastatic prostate cancer
This study is testing if using PET scans to guide radiation therapy can help men with metastatic prostate cancer live longer and have better treatment outcomes compared to standard treatments alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.