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

Recruiting Phase 3 Interventional Study
Castration-Sensitive Prostate Carcinoma Metastatic Prostate Adenocarcinoma Stage IVB Prostate Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,260 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
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About This 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…
Trial Locations
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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…
Contacts

Shiva Baghaie, MPH

(773) 702-9171

GUprotocols@alliancenctn.org

CONTACT