30 Participants Needed

HDR Brachytherapy for Prostate Cancer

AB
Overseen ByAlejandro Berlin, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-coagulative therapy (blood thinners), you may need to temporarily stop them during the brachytherapy treatment.

What data supports the effectiveness of the treatment HDR Brachytherapy for Prostate Cancer?

Research shows that HDR brachytherapy, whether targeted to specific areas or applied to the whole prostate gland, is effective in controlling prostate cancer. It allows precise targeting of cancer cells while minimizing damage to surrounding healthy tissue, and has been shown to improve outcomes in localized prostate cancer.12345

Is HDR Brachytherapy safe for treating prostate cancer?

Research suggests that HDR Brachytherapy, including focal and whole-gland approaches, is generally safe for treating prostate cancer, with studies indicating it has manageable levels of toxicity and can reduce side effects by targeting specific areas.13467

How is HDR Brachytherapy for Prostate Cancer different from other treatments?

HDR Brachytherapy for Prostate Cancer is unique because it can target specific areas of the prostate, reducing the radiation dose to surrounding organs and potentially leading to fewer side effects. This focal approach, often guided by advanced imaging techniques like MRI and ultrasound, allows for precise treatment of cancerous areas while sparing healthy tissue.13689

Eligibility Criteria

Men over 18 with early-stage, low to favorable intermediate-risk prostate cancer can join this study. They should be in good health (ECOG status 0-2), have a prostate size <80cc, and no history of severe rectal conditions or certain autoimmune diseases. No prior radiation or brachytherapy for the prostate is allowed, and they must not have any contraindications to MRI or anesthesia.

Inclusion Criteria

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
Absence of latex allergy
No contraindications to MRI: Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HDR brachytherapy, either whole-gland or targeted focal therapy based on MRI findings

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life improvements after treatment

12 weeks

Treatment Details

Interventions

  • Targeted Focal HDR Brachytherapy
  • Whole-gland HDR Brachytherapy
Trial OverviewThe trial is testing two types of high dose rate (HDR) brachytherapy treatments for localized prostate cancer: one that targets the whole gland and another that focuses on specific areas identified by MRI. The goal is to see if focal treatment reduces side effects while maintaining effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Tumour visible on MRIExperimental Treatment1 Intervention
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
Group II: No tumour visible on MRIActive Control1 Intervention
Whole-gland HDR Brachytherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

Focal high dose rate (HDR) brachytherapy for locally recurrent prostate cancer showed a biochemical progression-free survival rate of 63% at 2 years and 46% at 3 years among 50 patients, indicating its efficacy as a salvage treatment.
The treatment had acceptable toxicity levels, with no severe gastrointestinal toxicities and only a few cases of late grade 3 genitourinary issues, suggesting it is a relatively safe option for selected patients.
Single-Dose Focal Salvage High Dose Rate Brachytherapy for Locally Recurrent Prostate Cancer.Chitmanee, P., Tsang, Y., Tharmalingam, H., et al.[2020]
High-dose-rate (HDR) brachytherapy as a monotherapy for localized prostate cancer showed excellent outcomes, with a 5-year overall survival rate of 98.7% and biochemical control rate of 96.7% among 77 patients followed for a median of 57 months.
The treatment had an acceptable safety profile, with no severe (Grade 3 or higher) acute toxicities and only 24.6% of patients experiencing mild (Grade 2) genitourinary acute toxicity, indicating that HDR brachytherapy is both effective and safe for this condition.
High-dose-rate brachytherapy as a monotherapy for prostate cancer--Single-institution results of the extreme fractionation regimen.Kukiełka, AM., Dąbrowski, T., Walasek, T., et al.[2022]
High-dose-rate (HDR) focal brachytherapy for prostate cancer significantly reduces radiation exposure to surrounding organs at risk compared to standard whole gland treatment, with the most substantial reductions observed when treating only one-sixth of the gland.
In a study involving five patients, the HDR focal treatment achieved target dose objectives while minimizing damage to the bladder, rectum, and urethra, indicating a promising approach to reduce potential side effects, although further research is needed to assess its clinical impact on patient outcomes.
From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis.Banerjee, R., Park, SJ., Anderson, E., et al.[2018]

References

Single-Dose Focal Salvage High Dose Rate Brachytherapy for Locally Recurrent Prostate Cancer. [2020]
High-dose-rate brachytherapy as a monotherapy for prostate cancer--Single-institution results of the extreme fractionation regimen. [2022]
From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis. [2018]
Focal high-dose-rate brachytherapy for localized prostate cancer: toxicity and preliminary biochemical results. [2022]
HDR Prostate Brachytherapy. [2020]
Systematic Review of Focal Prostate Brachytherapy and the Future Implementation of Image-Guided Prostate HDR Brachytherapy Using MR-Ultrasound Fusion. [2022]
High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. [2020]
Single fraction multimodal image guided focal salvage high-dose-rate brachytherapy for recurrent prostate cancer. [2020]
Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. [2022]