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

Trial Summary

What is the purpose of this trial?

This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.

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 data supports the effectiveness of the treatment Prostate Brachytherapy for prostate cancer?

Research shows that ultrasound-guided prostate brachytherapy is effective in controlling prostate cancer while maintaining low levels of urinary and erectile difficulties. It is favored for its brief recovery period and fewer side effects compared to other treatments. ^{1 2 3 4 5}

Is ultrasound-guided prostate brachytherapy safe for humans?

Ultrasound-guided prostate brachytherapy is generally considered safe, with studies showing low levels of urinary and erectile difficulties. Common short-term side effects include urinary symptoms like frequency and discomfort, while rare complications may include urinary retention and rectal issues. Overall, it has a favorable side effect profile compared to other treatments. ^{1 2 3 6 7}

How is ultrasound-guided prostate brachytherapy different from other prostate cancer treatments?

Ultrasound-guided prostate brachytherapy is unique because it involves placing radioactive sources directly into the prostate gland using imaging guidance, allowing for higher radiation doses than other techniques. This method offers favorable outcomes with fewer side effects and a shorter recovery period compared to more invasive treatments like prostatectomy. ^{1 2 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Modern brachytherapy for localized prostate cancers: the northwest hospital (Seattle) experience. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional real-time magnetic resonance-guided interstitial prostate brachytherapy optimizes radiation dose distribution resulting in a favorable acute side effect profile in patients with clinically localized prostate cancer. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

AAPM Task Group 128: quality assurance tests for prostate brachytherapy ultrasound systems. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of complications between ultrasound-guided prostate brachytherapy and open prostate brachytherapy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A compact mechatronic system for 3D ultrasound guided prostate interventions. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Review on the effectiveness of prostate cancer brachytherapy]. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

A review of the recommendations governing quality assurance of ultrasound systems used for guidance in prostate brachytherapy. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Biopsy results after real-time ultrasound-guided transperineal implants for stage T1-T2 prostate cancer. [2016]

9. England pubmed.ncbi.nlm.nih.gov

The current role of imaging for prostate brachytherapy. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments. [2016]