Recruiting

HDR Brachytherapy

Sponsor:

University Health Network, Toronto

Code:

NCT00913939

Conditions

Patients With Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI Guided Needles to deliver HDR Brachytherapy

MRI Guided Needles to deliver HDR Brachytherapy

Study Details

Brief 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. 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.

Conditions

Patients With Prostate Cancer

Study ID

NCT00913939

Start date

May, 2009

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1: Salvage After EBRT

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).

active comparator: 2: Boost to EBRT

Patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.

Interventions

MRI Guided Needles to deliver HDR Brachytherapy

Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).

MRI Guided Needles to deliver HDR Brachytherapy

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.

Primary outcome measure

  • To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Peter Chung, MB ChB

416 946 4501Peter.chung@rmp.uhn.on.ca

Cynthia Ménard, MD

514 890-8000cynthia.menard.chum@ssss.gouv.qc.ca

Locations

University Health Network, Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Peter Chung, MB ChB

416 946 4501Peter.Chung@rmp.uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Prostate Cancer
  • HDR Brachytherapy
  • Prostate Brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-22.