What is SABR and HDR brachytherapy studying for prostate cancer?

This trial is studying a combination of one stereotactic ablative body radiotherapy (SABR) treatment with one MRI-guided high-dose rate (HDR) brachytherapy treatment for favorable-risk prostate cancer. Researchers want to find out if this approach can reduce treatment time, side effects, and costs while maintaining good cancer control. The Sunnybrook Health Sciences Centre is leading this study.

Who may be eligible for this prostate cancer clinical trial?

Men diagnosed with favorable-risk prostate adenocarcinoma with specific disease features and prostate volume under 60 cc may be eligible. Patients must have good baseline urinary function and be able to undergo MRI. Those with prior pelvic radiotherapy or prostate surgery are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the radiation treatments and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Phase 3

MALE

ID04654338

Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients EARTH

Led by Sunnybrook Health Sciences Centre · Updated on 2023-06-27

Participants Needed

Research Sites

234 weeks

Total Duration

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

MALE

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

Research Team

Merrylee McGuffin, MSc

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