What side effects are associated with this type of intervention?

High-dose rate (HDR) brachytherapy for prostate cancer can cause urinary symptoms such as urgency and frequency, which may persist in some patients. Bowel symptoms, including urgency and frequency, are also reported but are less common. Sexual dysfunction is a significant side effect, with many patients experiencing some degree of erectile dysfunction. External beam radiation therapy (RT) similarly affects sexual function and can cause bowel issues, such as increased frequency of bloody stools. Radical prostatectomy often results in worse urinary incontinence and sexual dysfunction compared to RT, with some recovery over time but persistent issues in many patients.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve targeted radiation. Radium-223, an alpha-emitting radioisotope, has been approved for men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. This treatment delivers high-energy radiation over a short distance, similar to HDR brachytherapy. Additionally, beta-emitting radioisotopes like strontium-89 and samarium-153 have been used clinically for bone metastases in prostate cancer. These treatments aim to target cancer cells directly with high doses of radiation, akin to the mechanism of HDR brachytherapy.

What other types of research exist?

Promising novel alternatives to HDR brachytherapy for prostate cancer patients include: 1) Radium-223, an alpha particle-emitting radiopharmaceutical that prolongs overall survival and decreases symptomatic skeletal-related events in castration-resistant prostate cancer with bone metastases. 2) PARP inhibitors like rucaparib and niraparib, particularly for patients with homologous recombination repair (HRR) gene mutations. 3) Combination therapies such as androgen deprivation therapy (ADT) plus docetaxel and darolutamide for high-risk/high-volume metastatic castration-sensitive prostate cancer. 4) External beam radiation therapy (EBRT) for bone pain management in castration-resistant prostate cancer.

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Brachytherapy

HDR Brachytherapy for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by CSSS de Gatineau

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gleason Score 6 or 7

Biopsy proven Adenocarcinoma of the Prostate

Must not have

IPSS score 19 or higher with alpha-blockers

Past radiation therapy to the pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 2 years and 5 years post treatment

Awards & highlights

Summary

This trial is studying HDR brachytherapy, a treatment that uses a small device to deliver strong radiation directly to prostate cancer cells. It targets patients with low and intermediate risk prostate cancer. The goal is to see if this method is effective and safe for these patients. High-dose-rate (HDR) brachytherapy is an advanced treatment for prostate cancer that allows precise delivery of high-dose radiation directly to the tumor, minimizing damage to surrounding tissues.

Who is the study for?

This trial is for men with prostate cancer that's not too advanced. Specifically, it's for those who've had a biopsy confirming Adenocarcinoma of the Prostate at an early stage (T1c, T2a or T2b), have a PSA level under 20 ng/ml, and a Gleason Score of 6 or 7.

What is being tested?

The study is testing if High-dose rate (HDR) brachytherapy alone can be effective in treating low to intermediate risk prostate cancer. HDR brachytherapy involves placing high-energy radiation sources inside the prostate to kill cancer cells.

What are the potential side effects?

Possible side effects from HDR brachytherapy may include discomfort during treatment, urinary issues like frequency or urgency, bowel changes, erectile dysfunction, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has a Gleason score of 6 or 7.

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My prostate cancer is confirmed by a biopsy.

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My breast cancer is in an early stage, but not the smallest size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My IPSS score is 19 or higher, and I am taking alpha-blockers.

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I have had radiation therapy to my pelvic area.

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I am under 18 years old.

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My cancer is at a stage where it has grown outside the organ it started in.

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My cancer has spread to other parts of my body.

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My prostate cancer is aggressive (Gleason score 8+).

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I have a history of collagen vascular disease.

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I have a history of inflammatory bowel disease.

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My cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 2 years and 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 2 years and 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 2 years and 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival

Secondary study objectives

Genito-urinary (GU) toxicity

Other study objectives

Gastro-Intestinal (GI) Toxicity

Trial Design

1Treatment groups

Experimental Treatment

Group I: HDR brachytherapy monotherapyExperimental Treatment1 Intervention

Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, and chemotherapy. Surgery involves the physical removal of the prostate gland, aiming to eliminate cancerous cells. Radiation therapy, such as High-dose rate (HDR) brachytherapy, delivers high doses of radiation directly to cancer cells, causing DNA damage that leads to cell death. Hormone therapy reduces levels of male hormones that can promote cancer growth, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, manage expectations, and understand potential side effects. Specifically, HDR brachytherapy's targeted approach can minimize damage to surrounding healthy tissues, offering a potentially effective treatment with fewer side effects.

Surgery or radiation: what is the optimal management for locally advanced prostate cancer?

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Who is running the clinical trial?

CSSS de GatineauLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

~6 spots leftby Mar 2026

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