Zapping just a few spots: new hope for patients with worsening metastatic cancer?
NCT ID NCT04122469
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Other studies related to the condition(s) this trial covers.
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