HDR vs LDR Brachytherapy for Prostate Cancer

(BrachyQOL Trial)

Overseen By Francois Bachand, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Prior malignancy, Prostatectomy, Pelvic irradiation, others

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

Compensation: Varies

Number of Visits: 6

190 Participants Needed

Trial Summary

What is the purpose of this trial?

Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Do I need to stop my current medications for the trial?

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

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

Research shows that low-dose-rate (LDR) brachytherapy is effective for controlling prostate cancer and has excellent long-term outcomes. While high-dose-rate (HDR) brachytherapy is also used, studies suggest LDR may offer superior tumor control compared to single-fraction HDR for prostate cancer. ^{1 2 3 4 5}

Is HDR and LDR brachytherapy safe for treating prostate cancer?

Research shows that both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are generally safe for treating prostate cancer, with studies reporting good safety profiles and outcomes. ^{1 2 3 6 7}

How does HDR vs LDR brachytherapy for prostate cancer differ from other treatments?

HDR (High-Dose Rate) and LDR (Low-Dose Rate) brachytherapy are unique treatments for prostate cancer that involve placing radioactive sources directly inside or near the tumor. HDR brachytherapy offers advantages like more precise dose control and the ability to treat areas outside the prostate, potentially leading to better local disease control and fewer side effects compared to traditional external beam radiotherapy. ^{1 2 3 4 8}

Research Team

Juanita M Crook, MD

Principal Investigator

British Columbia Cancer Agency

Eligibility Criteria

This trial is for men with intermediate to high-risk prostate cancer, who have not had surgery. They must have at least two of certain risk factors like a tumor stage T2B or higher, Gleason Score of 7, PSA over 10, or more than half their biopsies positive; or one high-risk factor like T3a stage, Gleason Score 8-10, or PSA over 20.

Inclusion Criteria

High risk prostate cancer with one of the following factors: T3a, Gleason Score 8-10, PSA > 20, Positive prostate biopsy within 6 months (reviewed centrally), International Prostate Symptom Score < 16, Prostate volume < 60 cc, Negative staging CT and Bone scan within 3 months prior to registration, History and physical examination within 90 days prior to registration, European Cooperative Oncology Group performance status 0-1 prior to registration, Age > 45, Patient suitable for procedure under anesthesia

My prostate cancer is intermediate risk with at least 2 of these: T2B or higher stage, Gleason Score 7, PSA over 10, more than half of biopsies positive.

Exclusion Criteria

I have been cancer-free for 3 years, except for non-melanoma skin cancer.

I have had surgery or specific treatments for prostate cancer.

I have had radiation treatment to my pelvis or seed implant therapy in my prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive external beam radiotherapy followed by either HDR or LDR brachytherapy boost

6-12 weeks

Androgen Deprivation Treatment

Participants may receive androgen deprivation treatment for 6 or 12 months

6-12 months

Follow-up

Participants are monitored for quality of life and PSA recurrence-free survival

5 years

Every 3 months for the first year, then every 6 months to 3 years

Long-term Follow-up

Participants are monitored for long-term quality of life and cancer-free status

10 years

Annually after 3 years

Treatment Details

Interventions

• HDR
• LDR

Trial Overview The study compares two types of brachytherapy 'boosts' added to external beam radiotherapy for prostate cancer: High Dose Rate (HDR) and Low Dose Rate (LDR). It aims to see if HDR leads to better survival rates without the disease getting worse and has fewer side effects and improved life quality compared to LDR.

Participant Groups

Group I: LDR boost Active Control 1 Intervention

After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy

Group II: HDR boost Active Control 1 Intervention

Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.

HDR is already approved in United States, European Union, Canada for the following indications:

Approved in United States as High-Dose Rate Brachytherapy for:

• Prostate cancer

Approved in European Union as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer

Approved in Canada as High-Dose Rate Brachytherapy for:

• Prostate cancer
• Gynecological cancers

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

BC Cancer Foundation

Collaborator

Trials

20

Recruited

8,600+

Findings from Research

A study of 50,326 patients with localized prostate cancer from 2004 to 2014 found that while both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are effective, the use of HDR has declined over time, from 27% in 2004 to 19.2% in 2014.

Despite similar overall survival rates (127.0 months for HDR and 125.4 months for LDR), factors such as age, treatment at academic centers, and income influenced the likelihood of receiving HDR over LDR, indicating a shift in treatment patterns rather than differences in efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment patterns of high-dose-rate and low-dose-rate brachytherapy as monotherapy for prostate cancer. Barnes, J., Kennedy, WR., Fischer-Valuck, BW., et al.[2023]

In a study of 201 patients treated with low-dose-rate (LDR) brachytherapy for localized prostate cancer, there was a significant and persistent decline in prostate-specific antigen (PSA) levels over time, indicating effective cancer control.

After 10 years of follow-up, only 9 patients experienced tumor recurrence, and while some urinary symptoms were noted initially, they significantly decreased after 18 months, suggesting that LDR brachytherapy is both safe and effective with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. D'hulst, P., Mattelaer, P., Darras, J., et al.[2022]

High dose rate (HDR) brachytherapy combined with external beam radiation therapy has been shown to be a safe and effective treatment for intermediate and high-risk prostate cancer, leading to a significant increase in treatment options and outcomes.

The success of HDR brachytherapy has prompted its use as a standalone treatment for low to intermediate-risk prostate cancer, supported by excellent toxicity profiles and clinical results from ongoing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of high dose rate brachytherapy in the treatment of prostate cancer. Ghilezan, M.[2012]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

References

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

LDR brachytherapy offers superior tumor control to single-fraction HDR prostate brachytherapy: A prospective study. [2023]

2. Poland pubmed.ncbi.nlm.nih.gov

Treatment patterns of high-dose-rate and low-dose-rate brachytherapy as monotherapy for prostate cancer. [2023]

3. Poland pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. [2022]

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

Transitioning From a Low-Dose-Rate to a High-Dose-Rate Prostate Brachytherapy Program: Comparing Initial Dosimetry and Improving Workflow Efficiency Through Targeted Interventions. [2022]

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

A comparative analysis of overall survival between high-dose-rate and low-dose-rate brachytherapy boosts for unfavorable-risk prostate cancer. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Role of high dose rate brachytherapy in the treatment of prostate cancer. [2012]

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

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. [2022]

8. England pubmed.ncbi.nlm.nih.gov

High Dose Rate Brachytherapy in High-Risk Localised Disease - Why Do Anything Else? [2021]