Prostate CancerNCT01802242
Tumor TARGET Prostate Cancer
A study testing Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy and No Active Treatment - completed Prior Radiation in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy and No Active Treatment - completed Prior Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2012to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria [applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified]:
- Histological evidence of prostate adenocarcinoma.
- 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) )
- At least 18 years old
- ECOG performance status 0 or 1
- 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).
- 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)
- Risk of LN involvement <30% (Roach formula = 2/3PSA([G-6]x10))
- 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]:
- Previous history of radiation therapy to the prostate (Cohort 2)
- Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)
- Patients weight as per MRI Technologist's discretion
- 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.
- Severe claustrophobia
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy
- Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort 2)
- Radiological evidence of regional or distant metastases (Cohort 2)
- Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy
- Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
- Contraindications to conscious sedation
- Latex allergy
- History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2)
- Other medical conditions deemed by the PI to make patient ineligible for study intervention
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9
About this study
Official title: Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer
Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Once diagnosed, most patients do require some form of treatment so that the prostate cancer does not progress to cause damage and/or shortened lifespan. Occasionally, after patients receive treatment, the investigators have found that an area of cancer remains within the prostate. Those patients with a large area of cancer (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate cancer even after standard treatment. Thus, the investigators believe that the area of the prostate gland occupied by a dense area of cancer may need more radiation therapy than normal to remain cancer free.
Standard therapy currently in place in North America: Currently patients who are diagnosed with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT) alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy alongside the radiation depending on their physician's preference. For those who receive radiation therapy, the tumor typically receives the same dose as the rest of the prostate gland.
Read more
Findings to date: In the past few years the investigators have discovered that patients with a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of having cancer remain in the prostate, despite receiving treatment for their cancer 3 years earlier. Using new technology investigators can deliver radiation therapy after viewing the prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumor within the prostate. Based on this earlier success the investigators believe that they can now safely give a higher dose of radiation to specifically target the cancer within the prostate gland.
Reason for the study: The investigators would like to test this technology and expertise to give radiation to a higher than normal dose to the tumor nodule in prostate gland.
Read the detailed description
This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy.
Cohort 1 (Control group): This group consists of patients who have had previous radiation. This group will not receive any active treatment but will have a biopsy at 3 years from the time they completed their radiation therapy. Patient in this group will also continue to have their PSA checked per standard practice
Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular standard of care PSA checks, this group will also complete a quality of life questionnaire and have regular imaging per standard practice.
Both groups will be followed by the research team per protocol.
- Conditions
- Prostate Cancer
- Being tested
- Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy, No Active Treatment - completed Prior Radiation
- Keywords
- Prostate Cancer, Prostate tumour, Prostate radiotherapy, prostate cancer treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) RadiotherapyRadiation
Patients in this group will receive one of 2 treatment arms of their choice:
- Arm 1: VMAT delivery with integrated VMAT boost (IB-VMAT) GTV: 95Gy in 38fractions
- Arm 2: HDR-boost followed by VMAT GTV: 10Gy HDR + 76Gy in 38 fractions VMAT
No Active Treatment - completed Prior RadiationOther
Already had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice
| Study group | Role | What they receive |
|---|---|---|
| Active Radiation Treatment (Cohort 2) | Experimental | Not described Receives: Radiation: Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy |
| Prior Radiation Treatment (Control Cohort) | Other | Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment Receives: Other: No Active Treatment - completed Prior Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer.
Measured: 5 years
Secondary outcomes (9)
Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow.
Measured: 5 years
Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost
Measured: 5 years
Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy
Measured: 5 years
Compare dose to recurrent and non-recurrent tumor nodules.
Measured: 5 years
Determine rates of toxicity with tumor-targeted boost radiotherapy.
Measured: 5 years
Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy.
Measured: 5 years
Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques
Measured: 5 years
Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.
Measured: 5 years
Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start23 Nov 2012
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Peter Chung, MB ChB, Principal investigator, University Health Network, The Princess Margaret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802242
- Sponsor's protocol ID
- UHN REB 12-5015-C
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2012
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01802242
- Acronym / sponsor ID
- UHN REB 12-5015-C
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate tumour, Prostate radiotherapy, prostate cancer treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 23 Nov 2012 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Once diagnosed, most patients do require some form of treatment so that the prostate cancer does not progress to cause damage and/or shortened lifespan. Occasionally, after patients receive treatment, the investigators have found that an area of cancer remains within the prostate. Those patients with a large area of cancer (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate cancer even after standard treatment. Thus, the investigators believe that the area of the prostate gland occupied by a dense area of cancer may need more radiation therapy than normal to remain cancer free.
Standard therapy currently in place in North America: Currently patients who are diagnosed with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT) alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy alongside the radiation depending on their physician's preference. For those who receive radiation therapy, the tumor typically receives the same dose as the rest of the prostate gland.
Findings to date: In the past few years the investigators have discovered that patients with a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of having cancer remain in the prostate, despite receiving treatment for their cancer 3 years earlier. Using new technology investigators can deliver radiation therapy after viewing the prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumor within the prostate. Based on this earlier success the investigators believe that they can now safely give a higher dose of radiation to specifically target the cancer within the prostate gland.
Reason for the study: The investigators would like to test this technology and expertise to give radiation to a higher than normal dose to the tumor nodule in prostate gland.
Detailed description
This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy.
Cohort 1 (Control group): This group consists of patients who have had previous radiation. This group will not receive any active treatment but will have a biopsy at 3 years from the time they completed their radiation therapy. Patient in this group will also continue to have their PSA checked per standard practice
Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular standard of care PSA checks, this group will also complete a quality of life questionnaire and have regular imaging per standard practice.
Both groups will be followed by the research team per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Radiation Treatment (Cohort 2) | Experimental | Radiation: Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy |
| Prior Radiation Treatment (Control Cohort) | Other | Other: No Active Treatment - completed Prior RadiationPatients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) RadiotherapyPatients in this group will receive one of 2 treatment arms of their choice: * Arm 1: VMAT delivery with integrated VMAT boost (IB-VMAT) GTV: 95Gy in 38fractions * Arm 2: HDR-boost followed by VMAT GTV: 10Gy HDR + 76Gy in 38 fractions VMAT | Radiation | Active Radiation Treatment (Cohort 2) |
| No Active Treatment - completed Prior RadiationAlready had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice | Other | Prior Radiation Treatment (Control Cohort) |
Primary outcome
Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer.
Time frame: 5 years
9 secondary outcomes
Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow.
Time frame: 5 years
Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost
Time frame: 5 years
Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy
Time frame: 5 years
Compare dose to recurrent and non-recurrent tumor nodules.
Time frame: 5 years
Determine rates of toxicity with tumor-targeted boost radiotherapy.
Time frame: 5 years
Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy.
Time frame: 5 years
Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques
Time frame: 5 years
Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.
Time frame: 5 years
Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Chung, MB ChB principal investigator
University Health Network, The Princess Margaret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy and No Active Treatment - completed Prior Radiation in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.