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

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 o

Trial Details

NCT ID
NCT06931340
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Androgen Therapy
  • Apalutamide
  • Docetaxel
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Bone Scan
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Dublin, California, United States|37.70215,-121.93579
  • Sacramento, California, United States|38.58157,-121.4944
  • Denver, Colorado, United States|39.73915,-104.9847
  • Lafayette, Colorado, United States|39.9936,-105.08971

Key Eligibility 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 a…
  • Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR

For full eligibility, visit ClinicalTrials.gov.

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