MICRO-ultrasound Guided Prostate SBRT

ConditionProstate Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This study will test whether it is safe and effective to use stereotactic body radiation therapy (SBRT)-a short, targeted form of radiation-together with a microultrasound (microUS)-guided radiation boost to the cancerous spots inside the prostate. Researchers will compare treatment plans that use microUS to plans created using the current standard method, which relies on MRI images, to determine whether microUS can successfully guide targeted radiation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed carcinoma of the prostate (biopsy results with 12 months of enrollment)

Intermediate risk as defined by NCCN criteria

Conventional imaging (bone scan and abdominal pelvic computed tomography) is mandatory for NCCN unfavourable intermediate risk prostate cancer patients with PSA > 10. Negative nodal, skeletal or visceral metastases within 16 weeks of enrollment (for patients requiring staging). Alternatively, patients with no signs of extra-prostatic disease on PSMA-PET scans are also candidates for this trial

ECOG performance status 0-1

Disqualifiers

Estimated prostate volume > 60cc (volume based on transrectal ultrasound)

Prior TURP

Prior prostate cancer treatment, including 5-alpha reductase inhibitor treatment

Low, high or very high-risk disease as per NCCN guidelines

Trial design

Design model

Parallel

Treatments tested in this trial

Stereotactic Body Radiation Therapy
Radiation
Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)
Stereotactic Body Radiation Therapy
Radiation
Micro-boost to the dominant intraprostatic lesions (DILs) of 40 Gray, with the rest of the prostate receiving 35 Gray. If no DILs identified, whole prostate stereotactic body radiation therapy with dose of 35 Gray. Both interventions to be given in 5 fractions on alternate days.
ExactVu
Device
microUltrasound

Treatment groups

112 Participants

are divided into 2 treatment groups

Group A: CT-Guided, mpMRI Assisted Whole Prostate SBRTActive comparator 1 intervention

Group B: CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion BoostExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26)

To evaluate if microUS-guided DIL boost with dose de-escalation to the remaining prostate results in superior acute GU patient-reported outcomes when compared to standard prostate SBRT, as measured by the Expanded Prostate Cancer Index (EPIC-26)

Time frame

From enrollment to 3 weeks after the end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: