Ultrasound-Guided Prostate Brachytherapy for Prostate Cancer

Overseen By Aaron Fenster

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Previous prostate radiotherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to guide prostate cancer treatment using ultrasound. Researchers aim to determine if adding vibrations to the needle can improve visibility during brachytherapy, a type of radiation treatment. The goal is to enhance the accuracy of treatment delivery. Men with confirmed prostate cancer who are prepared for high-dose-rate brachytherapy might be suitable candidates. Those who have previously undergone radiation therapy on the prostate are not eligible for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ultrasound-guided technique is safe for prostate cancer treatment?

Research has shown that prostate brachytherapy, a treatment involving the placement of tiny radioactive seeds in the prostate to combat cancer, is generally safe. Studies have found that patients receiving this treatment achieve similar outcomes to those undergoing surgery, with a high success rate in controlling cancer. Long-term results are encouraging, with 97% of patients surviving without dying from prostate cancer over many years.

While side effects can occur, studies have not identified any unusual or severe safety issues. Most patients tolerate the procedure well. This evidence suggests that prostate brachytherapy is a dependable and safe option for treating prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard prostate cancer treatments like surgery or external beam radiation, prostate brachytherapy involves placing radioactive seeds directly into the prostate. This technique targets cancer cells more precisely, minimizing damage to surrounding healthy tissue. Researchers are excited about using ultrasound guidance in this brachytherapy as it potentially enhances accuracy and effectiveness, offering a promising advancement in treating prostate cancer.

What evidence suggests that ultrasound-guided prostate brachytherapy is effective for prostate cancer?

Research has shown that prostate brachytherapy effectively controls prostate cancer. Studies have found that combining brachytherapy with external beam radiation therapy (EBRT) improves cancer control compared to using EBRT alone. Long-term results indicate that brachytherapy provides excellent disease control with few side effects over ten years. Additionally, randomized trials comparing low-dose-rate and high-dose-rate brachytherapy found both effective for treating intermediate and high-risk prostate cancer. This evidence suggests that brachytherapy is a reliable treatment option for managing prostate cancer. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older who have been diagnosed with prostate cancer and are suitable and consenting to high-dose-rate brachytherapy as standard care. Participants must be willing to provide written consent. Men who have had previous radiotherapy to the prostate cannot participate.

Inclusion Criteria

I agree to undergo high-dose-rate brachytherapy as part of my treatment.

I am a man aged 18 or older.

My prostate cancer was confirmed through a biopsy.

Exclusion Criteria

I have had radiation therapy to my prostate before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo standard care prostate high dose rate brachytherapy with power Doppler ultrasound for needle localization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prostate Brachytherapy

Trial Overview The study tests a new method of visualizing the placement of brachytherapy needles in the prostate using power Doppler ultrasound, which may enhance needle localization by making vibrations visible when an oscillator contacts the needle during treatment.

How Is the Trial Designed?

Group I: Patient Experimental Treatment 1 Intervention

Patient undergoing standard care prostate high dose rate brachytherapy.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

The robot-assisted transrectal ultrasound (TRUS)-guided prostate brachytherapy system successfully reached all clinically relevant locations in a prostate phantom, demonstrating its technical viability for precise needle placement.

The average placement errors for needle insertion were low, with a transverse error of 2 mm and a sagittal error of 2.5 mm, indicating that the system is inherently safe and effective, though further optimization is needed for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments. Fichtinger, G., Burdette, EC., Tanacs, A., et al.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40187573/

Efficacy Results After Median Follow-up of 74 Months Conclusions: In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in bPFS at 5 and 8 years and ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer However, studies have shown that combining brachytherapy with EBRT results in a higher rate of cancer control than EBRT alone. Nevertheless, the ...

3. urotoday.com urotoday.com/conference-highlights/astro-2024/astro-2024-prostate-cancer/155302-astro-2024-a-randomized-comparison-of-low-dose-rate-or-high-dose-rate-brachytherapy-combined-with-external-beam-radiation-for-unfavorable-intermediate-or-high-risk-prostate-cancer-efficacy-results-at-median-6-years.html

ASTRO 2024: A Randomized Comparison of Low Dose ... A randomized trial comparing low- and high-dose rate brachytherapy, combined with external beam radiotherapy, for intermediate- or high-risk prostate cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2287888223000041

The oncologic and safety outcomes of low-dose-rate ... Previous reports revealed that the long-term oncologic outcomes of LDR brachytherapy are superior to those of EBRT. The oncologic outcomes of low- to ...

5. uclahealth.org uclahealth.org/cancer/cancer-services/radonc/treatments/brachytherapy/prostate-cancer-brachytherapy

Prostate Cancer – Brachytherapy - Radiation Oncology Our 10 year results have shown excellent clinical control of disease and few side effects (2). Today, UCLA Division of Brachytherapy continues to be leaders in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10513906/

The oncologic and safety outcomes of low-dose-rate ... The oncologic outcomes of low- to intermediate-risk patients are equivalent to those of RP using the recurrence definition of surgery of prostate specific ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11779706/

Long-term outcomes of LDR-brachytherapy for localized ... The cancer-specific survival at the end of the follow-up was very high at 97%, as only seven patients (3%) died of prostate cancer during the ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)00001-9/fulltext

GEC-ESTRO ACROP prostate brachytherapy guidelines The combined brachytherapy cohort had significantly lower prostate cancer-specific mortality (HR 0.38 vs surgery and 0.41vs EBRT alone). However ...

9. tau.amegroups.org tau.amegroups.org/article/view/17950/html

High dose-rate brachytherapy in the treatment of prostate cancer In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...