2 Ablative RadioTherapy Treatments for Prostate Cancer — EARTH  

Prostate Cancer Clinical Trial

Official title: Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)

Status Recruiting

Clinical Trial 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 radiotherapy (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.

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04654338
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Contact: Merrylee McGuffin, MSc
• Phone: 416-480-6100
• Email: Merrylee.Mcguffin@sunnybrook.ca
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 29, 2020
• Completion date: July 29, 2028