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Genetic clues could personalize prostate cancer therapy

NCT ID NCT03348670

Knowledge-focused Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how genetic differences (SNPs) in prostate cancer patients affect their response and side effects to the drug abiraterone. Researchers will analyze DNA from 600 patients taking abiraterone plus prednisone and bicalutamide. The goal is to find genetic markers that predict effectiveness and toxicity, which could help tailor treatment to each patient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abiraterone acetate (Zytiga) plus prednisone and bicalutamide
What this could lead to
If successful, this could help doctors predict which prostate cancer patients will benefit most from abiraterone and who might have side effects, leading to more personalized treatment.
What could go wrong
This is an observational genetic study, not a test of a new drug. It may not lead to immediate changes in treatment, and genetic markers may not reliably predict outcomes in all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Select 600 localized Prostate Cancer Patients without prostate resection * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, like as the usual approach group. * The study approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, like as the study approach group. Inclusion Criteria: 1. Clinical diagnosis of Prostate Cancer (PC) 2. Cancer in the prostate only 3. Prior therapy without orchiectomy 4. Prior therapy without prostate resection 5. Prior different chemotherapy must-need stop 6. Have no other cancer at the same time 7. Sign an informed consent form 8. Receive blood-drawing Exclusion Criteria: 1. Treatment with other anti-cancer therapies and the therapies cannot be stopped currently 2. The patients with other serious intercurrent illness or infectious diseases 3. Have more than one different kind of cancer at the same time 4. Serious Allergy to Drugs 5. Serious Bleed Tendency 6. Serious Risks or Serious Adverse Events of the drug product label 7. Serious Risks or Serious Adverse Events of NCI Table of Side Effects 8. The prohibition of drug products 9. Have no therapeutic effects 10. Follow up to the most current label and plan for safety monitoring

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Conditions

The condition(s) this trial relates to.

neoplasm prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

    Rockville, Maryland, 20853, United States

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