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New hope for indian men with advanced prostate cancer: enzalutamide under study

NCT ID NCT03641560

Disease control Sponsor: Astellas Pharma Inc 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of enzalutamide (Xtandi) in 52 Indian men with metastatic castration-resistant prostate cancer that had worsened after chemotherapy. Participants took enzalutamide daily while continuing hormone therapy. The main goal was to see how many experienced side effects, and researchers also measured PSA levels to gauge response.

What this could mean

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

Active substance
enzalutamide (Xtandi)
What this could lead to
If successful, this could confirm that enzalutamide is safe and effective for Indian patients with advanced prostate cancer, offering a treatment option after chemotherapy.
What could go wrong
This is a small, single-arm study with no placebo group, so results may not be generalizable. Side effects are possible, and the drug may not work for everyone.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

52 people

The number who actually took part.

Started

Sep 2018

Finished

Feb 2024

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

18 years and older

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.

Inclusion Criteria: * Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. * Subject with established diagnosis of metastatic castration-resistant prostate carcinoma. * Subject is being newly initiated on Xtandi treatment (Enzalutamide). * Subject has an estimated life expectancy of ≥ 6 months. * Subject agrees not to participate in another interventional study while participating in the present study. Exclusion Criteria: * Subject who is not eligible to receive Xtandi as per the locally approved prescribing information. * Subject participating or planning to participate in any interventional drug trial during the course of this trial. * Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening. * Subject has any condition which makes the subject unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

  • Site IN00001

    Pune, India

  • Site IN00002

    Ahmedabad, India

  • Site IN00003

    Nashik, India

  • Site IN00004

    Hubli, India

  • Site IN00007

    Nashik, India

  • Site IN00008

    Kolkata, India

  • Site IN00010

    New Delhi, India

  • Site IN00011

    Surat, India

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