Actively Recruiting
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Led by Sunnybrook Health Sciences Centre · Updated on 2023-06-27
30
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prostate cancer patients with favorable-risk disease are commonly treated with lengthy courses of image guided radiation therapy (IGRT). Researchers are investigating a shorter, more convenient approach by combining one stereotactic ablative body radiotherapy (SABR) treatment with one high-dose rate (HDR) brachytherapy treatment guided by MRI. This study aims to assess if this combined approach can maintain good cancer control while reducing side effects, treatment time, and costs. Participants will first undergo imaging and marker placement to prepare for treatment. Then they receive one SABR treatment delivering a high dose to the prostate and seminal vesicles. About one week later, imaging is repeated to plan a single HDR brachytherapy dose targeted to the prostate and visible tumor areas. Both treatments use imaging guidance to accurately deliver radiation. Dosimetric data will be collected during treatment. Patients will be monitored closely from the start of SABR treatment through five years. Assessments include evaluations of urinary, rectal, and sexual function, side effects at multiple time points, blood tests for PSA and testosterone, and quality of life questionnaires. Samples of urine, blood, and biopsy tissue will be collected before and after treatment for further study. This thorough follow-up aims to track safety, side effects, quality of life, and cancer control over time.
CONDITIONS
Brief Title
2 Ablative RadioTherapy Treatments for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Favorable risk disease defined as either low risk (T1-T2c, grade group 1, PSA < 10 ng/ml) or favorable intermediate risk (one of T2c, grade group 2, or PSA 10-20 ng/ml) with percent core positivity ≤ 50%
- Prostate volume less than 60 cc as determined by ultrasound, CT, or MRI
- Ability to undergo MR imaging
- Provide written informed consent
You will not qualify if you...
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous transurethral resection of prostate, prostatectomy, or high-intensity focused ultrasound (HIFU)
- Use of androgen deprivation therapy; use of 5-alpha-reductase inhibitors is permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) > 15
- Contraindications to radical prostate radiotherapy such as connective tissue disease or inflammatory bowel disease
- Significant medical co-morbidity making patient unsuitable for general anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 weeks
Participants undergo planning imaging and biopsy procedures, including CT, mpMRI, TRUS, and insertion of gold seed fiducial markers, along with biobanking of urine, blood, and biopsy tissue.
1 to 2 visits for imaging and biopsy
Duration - 1 day
Participants receive one Stereotactic Ablative Body Radiation (SABR) treatment to the whole prostate and seminal vesicles with imaging for treatment setup.
1 treatment visit (in-person)
Duration - Approximately 1 week
Participants undergo planning imaging with mpMRI and TRUS and biobanking of urine and blood after SABR treatment.
1 imaging visit
Duration - 1 day
Participants receive one high-dose-rate brachytherapy treatment to the prostate and MRI-visible lesion.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants have assessments for acute and late toxicities, bloodwork, symptom scores, quality of life questionnaires, and post-treatment biobanking over 5 years.
Visits at weeks 6, 12, 24; months 3, 6, 9, 24; and every 6 months until year 5
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
M
Merrylee McGuffin, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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