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New combo therapy aims to control early-spread prostate cancer

NCT ID NCT04619069

Disease control Sponsor: Sunnybrook Health Sciences Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding a precise type of radiation (SBRT) to intermittent hormone therapy can better control prostate cancer that has spread to a few places in the body. The trial involves 60 men whose cancer was detected by a special PET scan but not by standard scans. The main goal is to see how many patients are willing to join the study, and researchers will also track side effects and how well the treatment works.

What this could mean

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

Active substance
Stereotactic body radiotherapy (SBRT) and intermittent hormone therapy
What this could lead to
If successful, this could show that adding targeted radiation to hormone therapy helps control prostate cancer that has spread to a few spots, potentially delaying disease progression.
What could go wrong
This is an early feasibility study with only 60 participants, so results may not be conclusive. The added radiation could cause side effects, and the benefit over hormone therapy alone is not yet proven.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

60 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Dec 2030

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 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: 1. Age \> 18 years. 2. Able to provide informed consent. 3. Histologic diagnosis of prostate adenocarcinoma. 4. ECOG performance status 0-1. 5. Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT. 6. Up to a maximum of 3 PSMA avid areas of metastatic disease. 7. For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be \> 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate. 8. All sites of disease are amenable to and can be safely treated with SBRT. Exclusion Criteria: 1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT. 2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer. 3. Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed. 4. Castrate resistant prostate cancer. 5. Evidence of spinal cord compression.

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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.

Prostate cancer

Contacts and locations

Locations

  • Odette Cancer Centre

    Toronto, Ontario, M4N3M5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.