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Zapping just a few spots: new hope for patients with worsening metastatic cancer?

NCT ID NCT04122469

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether using highly focused radiation (SBRT) on a limited number of growing cancer spots can help control the disease in patients with metastatic breast or genito-urinary cancers. Instead of switching to a new drug when some tumors start growing, doctors will target only those spots with radiation. The goal is to safely delay further progression and improve quality of life. About 130 adults will be followed for up to 2 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

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

Started

Sep 2019

Expected to finish

Sep 2027

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

Anyone

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: * Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre * 5 or less sites of intra or extra-cranial oligo-progressive, de novo oligo-metastatic, induced oligo-metastatic and repeat oligo-metastatic breast disease amenable to ablative treatment (including but not limited to radiotherapy, surgery, radio-frequency ablation); o at least one lesion should be planned for SBRT * OR 5 or less sites of intra or extra-cranial oligo-progressive prostate, bladder and renal cell carcinomas * Tumor mass amenable to SABR (≤6cm in size) * Confirmation of diagnosis: * Known/documented prior histological (for all excluding HCC) or radiological diagnosis (for HCC) of: * Pathologically confirmed breast cancer OR, * Pathologically confirmed GU cancer (such as prostate cancer, bladder cancer, or radiologically or pathologically confirmed RCC). * For prostate patients only: Known metastatic disease treated with ADT (patients who received other ST as first line treatment of mCSPC would be eligible; eg Docetaxel, Abiraterone…) * For prostate patients only: Known metastatic CRPC progressing on ST (Docetaxel, Abiraterone, Enzalutamide…) * For oligo-progressive disease: receiving any form of ST for at least 3 months with (ST breaks are permitted): 1. Radiographic evidence of ≤3 intra or extra-cranial lesions progressing (including nodal or distant). At least one lesion is suitable for SBRT. Each progressing lesion should fulfill at least 1 of the 3 following criteria for oligo-progression: 1. Progression of a metastasis according to RECIST 1.1 criteria7 2. Unambiguous development of a new lesion from the time of scan taken prior to starting ST 3. Progressive enlargement of a known metastasis on 2 consecutive imaging (CT or MRI) 2-3 months apart, while on ST, with a minimum 5 mm increase in size from baseline. 2. Remainder of metastatic disease stable or regressing, as per RECIST v1.1, evidenced by \>2 consecutive images within the past 4-6 months. * Able to provide written consent * ECOG performance status 0-3 Exclusion Criteria: * ≥6 progressive metastases * Evidence of spinal cord compression or acute event requiring urgent/emergency radiotherapy * Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk * Previous radical RT in the area of OP * Inability to safely treat all sites of progressing metastases * Patient cannot tolerate physical set-up required for SBRT * Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved * Active bowel obstruction, if treating abdominal/pelvic site * Neuroendocrine, lymphoma, myeloma or germ cell malignancies * Familial syndromes: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuberous Sclerosis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

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