Official Title
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Summary:
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with
prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these
patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative
body radiation therapy (SABR) protocols hold the promise of more convenience, less side effects,
less cost and improved system capacity without sacrificing excellent cancer control rates. By
the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be
superior to standard external beam radiation. While two HDR fractions appear to optimize
patient convenience and outcomes while minimizing costs, we wanted to determine the
tolerability of combining one MR-guided HDR treatment with one SABR treatment to further
reduce HDR resource use while maintaining favourable treatment outcomes.
Trial Description
Primary Outcome:
Secondary Outcome:
Pre-Treatment:
Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial
Markers Biobanking of urine, blood and biopsy tissue (as per REB - 079-2006 Odette Cancer
Centre (OCC) biobanking protocol)
Stereotactic Ablative Body Radiation (SABR):
13.5Gy x 1 to whole prostate + 1cm seminal vesicles 2 weeks post-planning, treatment will be
delivered as per standard treatment protocols on SABR-compatible linear accelerator with a
six-degree of freedom couch. Cone-beam CT imaging will be performed using the implanted
fiducials to set up each treatment. All dosimetric parameters will be recorded.
Inter-treatment (approx 1 week post-SABR):
Planning mpMRI and TRUS imaging for HDR Biobanking of urine and blood (as per REB - 079-2006
OCC biobanking protocol)
HDR brachytherapy:
13.5 Gy x 1 to the prostate, <20 Gy to DIL Approx 2-3 weeks post-SABR, the HDR dose
prescription of 13.5 Gy to the whole gland and <20 Gy to MRI visible lesion will be delivered
in one fraction, assuming that dose constraints to critical organs can be met. All dosimetric
parameters will be recorded
Patient Assessments / Follow-up Time zero will be the date of SABR treatment. Baseline
rectal, urinary and sexual function will be recorded prior to treatment. Acute toxicities
will be assessed at 6, 12 and 24 weeks and late toxicities will be assessed at month 9, 24
and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, V 4.0.
Bloodwork (PSA and testosterone) and International Prostate Symptom Score (IPSS) evaluations
will be performed at baseline week 6, month 3, 6, 9 and 24, and every 6 months until year 5.
QOL using the Expanded Prostate Cancer Index Composite (EPIC), EQ-5D and PORPUS
questionnaires will be obtained at baseline, month 3, 6, 9 and 24 and every 6 months until
year 5. Post-treatment biobanking will be done at 13 and 52 weeks (as per REB
- 079-2006 OCC
biobanking protocol)
View this trial on ClinicalTrials.gov
