Patients With Prostate CancerNCT00913939
High-Dose-Rate Brachytherapy
A study testing MRI Guided Needles to deliver HDR Brachytherapy in people with Patients With Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This pilot study initiates a research program testing the early technical and clinical performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy. Testing will proceed in two cohorts of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Patients With Prostate Cancer
- What is being tested?
- MRI Guided Needles to deliver HDR Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Prior enrollment of UHN 05-0641-C or UHN 12-5015-C (Arm 1)
- Histological evidence of recurrent prostate adenocarcinoma (Arm 1)
- PSA doubling time > 6 months (Arm 1)
- Intermediate and High-risk localized prostate cancer (>T1 or PSA>10 or Gleason > 6) (Arm 2)
- Planned for EBRT + HDR boost (+/- hormone therapy) (Arm 2)
- ECOG 0 or 1
- Age > 18 years
- 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.
Who cannot join
- Radiological evidence of regional or distant metastases
- Contraindications to MRI (Patient weight as per MRI Technologist's discretion, Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI)
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
- Previous prostate brachytherapy
- Active hormonal therapy at time of brachytherapy (Arm 1)
- Previous pelvic radiotherapy (Arm 2)
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- Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery.
- Latex Allergy
- Contraindications to conscious sedation, local anesthesia, or spinal/epidural anesthesia.
- IPSS >18
- Large TURP defect
- TURP within the past 6 months
- Prostate gland size >80cc (Arm 2, whole gland HDR patients only)
- History of Ulcerative Colitis and SLE (except for patients where the clinician determines benefit outweighs the risk of radiation)
- Other medical conditions deemed by the PI to make patient ineligible for MRI-guided Prostate HDR brachytherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Peter Chung, MB ChB, 416 946 4501 ext. 6522, Peter.Chung@rmp.uhn.on.ca
About this study
Official title: MRI-Guided HDR Brachytherapy for Prostate Cancer
This pilot study initiates a research program testing the early technical and clinical performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy. Testing will proceed in two cohorts of patients. In Arm 1, patients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.
This technique will be prospectively evaluated in up to 500 patients. Preliminary data acquired in this pilot study will determine the technical limits of MRI guided HDR brachytherapy and will be critical for the judicious conduct of a subsequent phase II clinical trial.
This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor targeting for HDR brachytherapy. Successful completion of this study will further individualize local therapy, not only for the benefit of the proportion of cancer patients for whom initial radiotherapeutic interventions have failed, but also provide valuable technical and clinical validation that these novel image-guided (IG) approaches are clinically feasible and could be applied more broadly in prostate cancer therapy.
Read the detailed description
Two hundred and nineteen thousand new cases of prostate cancer have been projected in the Unites States for 2007, with external beam radiotherapy (EBRT) constituting the mainstay of local therapy for an increasing proportion of newly diagnosed patients. Despite improvements in the delivery and reduction in associated toxicity of external beam radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of patients. Local disease after EBRT is a risk factor for subsequent metastatic progression and prostate cancer-specific mortality, and is a cause of morbidity including hematuria, obstructive uropathy, and chronic pain. Given its prevalence, and the lack of satisfactory local salvage treatments, fear of prostate cancer recurrence has been shown to impose a substantial burden of suffering in patients.
Stereotactic needle placement under MRI-guidance enables two critical steps in tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor recurrence, and 2) permitting treatment planning and delivery to be based on 3D MRI images. MRI-based HDR brachytherapy will precisely identify the location of brachytherapy catheters relative to the target volumes and adjacent normal structures at risk of radiation injury, obviating the need for invasive saturation (24-100) mapping biopsies.
This study will build the evidence supporting the concept of MRI-guidance and tumor-targeted HDR brachytherapy in the management of prostate cancer. This trial will strive to demonstrate improvements in technical performance under MRI-guidance, while exploring a novel paradigm of patient-specific modulation of dose intensity based on regions of tumor burden.
- Conditions
- Patients With Prostate Cancer
- Being tested
- MRI Guided Needles to deliver HDR Brachytherapy
- Keywords
- Prostate Cancer, HDR Brachytherapy, Prostate Brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Guided Needles to deliver HDR BrachytherapyProcedure or surgery
Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).
MRI Guided Needles to deliver HDR BrachytherapyProcedure or surgery
Patients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT.
| Study group | Role | What they receive |
|---|---|---|
| 1: Salvage After EBRT | Active comparator | Patients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). Receives: Procedure: MRI Guided Needles to deliver HDR Brachytherapy |
| 2: Boost to EBRT | Active comparator | Patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy. Receives: Procedure: MRI Guided Needles to deliver HDR Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.
Measured: 5 years
Secondary outcomes (2)
determine if prostate targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance as boost to EBRT;if tumor-targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance
Measured: 5 years
determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose.
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 posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With 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
- 500 participants (estimated)
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, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913939
- Sponsor's protocol ID
- UHN REB 09-0026-C
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2009
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
- MRI-Guided HDR Brachytherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00913939
- Acronym / sponsor ID
- UHN REB 09-0026-C
- Conditions
- Patients With Prostate Cancer
- Keywords
- Prostate Cancer, HDR Brachytherapy, Prostate Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- May 2009
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Jun 2009 (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.
This pilot study initiates a research program testing the early technical and clinical performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy. Testing will proceed in two cohorts of patients. In Arm 1, patients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.
This technique will be prospectively evaluated in up to 500 patients. Preliminary data acquired in this pilot study will determine the technical limits of MRI guided HDR brachytherapy and will be critical for the judicious conduct of a subsequent phase II clinical trial.
This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor targeting for HDR brachytherapy. Successful completion of this study will further individualize local therapy, not only for the benefit of the proportion of cancer patients for whom initial radiotherapeutic interventions have failed, but also provide valuable technical and clinical validation that these novel image-guided (IG) approaches are clinically feasible and could be applied more broadly in prostate cancer therapy.
Detailed description
Two hundred and nineteen thousand new cases of prostate cancer have been projected in the Unites States for 2007, with external beam radiotherapy (EBRT) constituting the mainstay of local therapy for an increasing proportion of newly diagnosed patients. Despite improvements in the delivery and reduction in associated toxicity of external beam radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of patients. Local disease after EBRT is a risk factor for subsequent metastatic progression and prostate cancer-specific mortality, and is a cause of morbidity including hematuria, obstructive uropathy, and chronic pain. Given its prevalence, and the lack of satisfactory local salvage treatments, fear of prostate cancer recurrence has been shown to impose a substantial burden of suffering in patients.
Stereotactic needle placement under MRI-guidance enables two critical steps in tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor recurrence, and 2) permitting treatment planning and delivery to be based on 3D MRI images. MRI-based HDR brachytherapy will precisely identify the location of brachytherapy catheters relative to the target volumes and adjacent normal structures at risk of radiation injury, obviating the need for invasive saturation (24-100) mapping biopsies.
This study will build the evidence supporting the concept of MRI-guidance and tumor-targeted HDR brachytherapy in the management of prostate cancer. This trial will strive to demonstrate improvements in technical performance under MRI-guidance, while exploring a novel paradigm of patient-specific modulation of dose intensity based on regions of tumor burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Salvage After EBRT | Active comparator | Procedure: MRI Guided Needles to deliver HDR BrachytherapyPatients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). |
| 2: Boost to EBRT | Active comparator | Procedure: MRI Guided Needles to deliver HDR BrachytherapyPatients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Prior enrollment of UHN 05-0641-C or UHN 12-5015-C (Arm 1)
- Histological evidence of recurrent prostate adenocarcinoma (Arm 1)
- PSA doubling time > 6 months (Arm 1)
- Intermediate and High-risk localized prostate cancer (>T1 or PSA>10 or Gleason > 6) (Arm 2)
- Planned for EBRT + HDR boost (+/- hormone therapy) (Arm 2)
Key exclusion criteria (15 listed)
- Radiological evidence of regional or distant metastases
- Contraindications to MRI (Patient weight as per MRI Technologist's discretion, Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI)
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
- Previous prostate brachytherapy
- Active hormonal therapy at time of brachytherapy (Arm 1)
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 |
|---|---|---|
| MRI Guided Needles to deliver HDR BrachytherapyPatients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days). | Procedure or surgery | 1: Salvage After EBRT |
| MRI Guided Needles to deliver HDR BrachytherapyPatients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT. | Procedure or surgery | 2: Boost to EBRT |
Primary outcome
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.
Time frame: 5 years
2 secondary outcomes
determine if prostate targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance as boost to EBRT;if tumor-targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance
Time frame: 5 years
determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Peter Chung, MB ChB principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Guided Needles to deliver HDR Brachytherapy in people with Patients 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?
The sponsor lists 8 inclusion and 15 exclusion criteria. 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Chung, MB ChB (416 946 4501 ext. 6522, Peter.chung@rmp.uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance. (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.