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NCT06931340PHASE3RECRUITING

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

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

Sponsor: Alliance for Clinical Trials in Oncology + National Cancer Institute (NCI)

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Androgen Therapy, Apalutamide, Docetaxel, Computed Tomography
Enrollment
1,260 participants
Primary completion
Nov 2031
Study completion
May 2039
First posted
Apr 2025
Last updated
May 2026

Primary Endpoints (CT.gov)

Overall survival (OS)

Time frame: From randomization to death due to any cause, assessed up to 10 years

Secondary Endpoints

Overall Survival (OS)

Radiographic progression

Castration-resistant prostate cancer (CRPC)

Eligibility 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/vis

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov