Zapping prostate tumors with extra radiation: a new targeted approach
NCT ID NCT01802242
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether giving a higher dose of radiation specifically to the visible tumor inside the prostate could improve cancer control in men with localized prostate cancer. Eighty-five men either received a standard radiation plan with an extra boost to the tumor or a combination of internal and external radiation. The goal was to see if this targeted approach could safely reduce the chance of cancer remaining after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (VMAT and HDR radiotherapy)
- What this could lead to
- If successful, this approach could become a standard way to give a higher, more precise radiation dose to the main tumor, potentially reducing the chance of cancer returning in the prostate.
- What could go wrong
- This was a small, single-center study without a control group, so results may not apply broadly. Higher radiation doses also carry a risk of increased side effects to nearby organs.
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
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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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85 people
The number who actually took part.
- Started
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Nov 2012
- Finished
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Mar 2020
- 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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Male participants only
- 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.
Show the full entry requirements Hide 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 \[applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified\]: 1. Histological evidence of prostate adenocarcinoma. 2. Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (\>5mm maximum diameter but \<33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) ) 3. At least 18 years old 4. ECOG performance status 0 or 1 5. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies). 6. Patients will be one of the following risk groups prior to therapy: * Low-risk disease (Gleason 6 and PSA \<10 and T1) AND \>50% of biopsy cores involved with tumor * Intermediate-risk disease (Gleason 7 or PSA 10-20 or T2) * High-risk disease (Gleason \>8 or T3 or PSA \>20) 7. Risk of LN involvement \<30% (Roach formula = 2/3PSA(\[G-6\]x10)) 8. Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment (Cohort 1 only) Exclusion Criteria \[applicable to both Cohorts 1 (control) and Cohort 2(Experimental) unless otherwise specified\]: 1. Previous history of radiation therapy to the prostate (Cohort 2) 2. Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2) 3. Patients weight as per MRI Technologist's discretion 4. Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist. 5. Severe claustrophobia 6. Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy 7. Current hormonal therapy (Cohort 1) or initiated \>2 weeks prior to enrollment (Cohort 2) 8. Radiological evidence of regional or distant metastases (Cohort 2) 9. Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy 10. Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery 11. Contraindications to conscious sedation 12. Latex allergy 13. History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2) 14. Other medical conditions deemed by the PI to make patient ineligible for study intervention
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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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University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a One-Week radiation course match four weeks for prostate cancer?
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- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains