Docetaxel with Hormonal Therapy for Metastatic Prostate Cancer

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
Who this trial is looking for

This trial is looking for men with advanced prostate cancer that has spread to other parts of the body. Participants will receive a combination of docetaxel chemotherapy along with their regular hormone therapy and apalutamide to see if it works better than just the hormone treatments alone.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have prostate cancer that has spread to other parts of my body.
  • I am at least 18 years old.
  • I have no prior chemotherapy for prostate cancer.
  • I have a good performance status and can carry out daily activities.
  • I have adequate blood cell counts.
  • I have had certain tests available at registration.
  • I agree to use birth control if I am sexually active.

You may not be able to join if

  • I have had a heart attack in the past six months.
  • I have uncontrolled high blood pressure.
  • I am allergic to any of the study drugs.
  • I have a history of seizures or conditions that cause seizures.
  • I have certain types of liver disease or untreated HIV.
  • I have more than 4 bone metastases or any visceral metastases.
  • I am currently taking strong CYP3A4 inhibitors or inducers.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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