Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Androgen Therapy — DRUG
  Given ADT
• Apalutamide — DRUG
  Given PO
• Docetaxel — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Bone Scan — PROCEDURE
  Undergo Bone Scan
• PSMA PET Scan — PROCEDURE
  Undergo PSMA PET Scan
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Questionnaire Administration — OTHER
  undergo Questionnaire Administration

Study Details

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.

Key Dates

Start date

Dec 1, 2025

Status verified

Jun 2026

Primary completion

Nov 11, 2031

Completion

May 8, 2039

Study Design

Enrollment

1,260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (ADT, apalutamide)
  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.
• Experimental: Arm 2 (ADT, apalutamide, docetaxel)
  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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to death due to any cause, assessed up to 10 years ]

Central Contacts

• Shiva Baghaie, MPH
  (773) 702-9171
  [email protected]

Locations (194)

Find similar trials in Tucson, AZ

Related Studies

• Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
  PHASE3 · Recruiting · SWOG Cancer Research Network · Gilbert, Arizona
• Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
  PHASE1/PHASE2 · Recruiting · National Cancer Institute (NCI) · Duarte, California
• Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
  PHASE3 · Recruiting · ECOG-ACRIN Cancer Research Group · Anchorage, Alaska