High-Dose-Rate Brachytherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI Guided Needles to deliver HDR Brachytherapy

    Procedure/Surgery

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

  • MRI Guided Needles to deliver HDR Brachytherapy

    Procedure/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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: 1: Salvage After EBRTActive comparator 1 intervention
Group B: 2: Boost to EBRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.

Time frame
5 years

Secondary outcomes

1

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
2

determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose.

Time frame
5 years

Other outcomes

Sponsors and contacts

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University Health Network, Toronto

Lead sponsor

Princess Margaret Hospital, Canada

Collaborator