HDR Focal: Feasibility Study (NCT02918253) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HDR Focal: Feasibility Study
Canada60 participantsStarted 2016-10-14
Plain-language summary
Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life.
This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer. Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function.
This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* ECOG performance status 0 - 2
* Histological evidence of prostate adenocarcinoma
* Low- and favorable intermediate-risk prostate cancer
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
* No contraindications to MRI
* Absent or unifocal intraprostatic disease (\<2 separate/distinct lesions), on multiparametric MRI
* Baseline IPSS \<18
* No TURP within the past 6 months, nor large TURP defect
* Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
* No previous pelvic and/or prostate EBRT and/or brachytherapy
* No contraindications to general anesthesia, or spinal/epidural anesthesia
* Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
* No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
* Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (except for patients where clinician determines benefit outweighs the risk of radiation)
* Absence of latex allergy
* No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.