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New hope for men with early spread prostate cancer: shorter drug course may boost quality of life

NCT ID NCT05404139

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This study looks at men whose prostate cancer has spread to a few spots in the body (oligometastatic). It compares standard radiation and hormone therapy alone versus adding the drug abiraterone for 8-9 months. The goal is to see if the extra drug improves quality of life and delays cancer progression. About 132 men will take part, and they will be followed for up to 5 years.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 352 people

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

Started

May 2023

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 100 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.

Inclusion Criteria: 1. Age \> 18 years 2. Able to provide informed consent 3. Histologic diagnosis of prostate adenocarcinoma 4. ECOG performance status 0-2 5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases 1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR) 2. Additional metastases can be detectable by PSMA PET only 6. All sites of disease are amenable to and can be safely treated with radiotherapy 7. Patients decline continuous use of ADT Exclusion Criteria (for all patients): 1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3. 2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively 3. Prior use of salvage systemic therapy 4. Evidence of spinal cord compression Exclusion Criteria (for Arm 4 only, after randomization) 1. ALT/AST \> 3 x ULN 2. History of myasthenia gravis or active myasthenia gravis 3. History of ocular myasthenia or active ocular myasthenia

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Sunnybrook Research Institute

    ACTIVE_NOT_RECRUITING

    Toronto, Ontartio, M4N 3M5, Canada

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