HDR vs. LDR Brachytherapy for Prostate Cancer

Overseen By Francois Bachand, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: British Columbia Cancer Agency

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prior prostate surgery, Prior chemotherapy, Prior pelvic radiation, Claustrophobia, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2-4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two types of internal radiation treatments for men with intermediate risk prostate cancer. One method uses slow-releasing radioactive seeds, while the other delivers a quick, high-intensity dose. The goal is to see if the quicker method leads to faster recovery and fewer side effects.

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

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have had androgen deprivation therapy (a treatment to lower male hormones).

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. ^{1 2 3 4 5}

Is HDR or LDR brachytherapy safe for humans?

There is growing evidence that both high-dose-rate (HDR) and low-dose-rate (LDR) brachytherapy are safe for treating prostate cancer, with studies reporting positive safety and quality outcomes. ^{1 2 5 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 in or near the tumor. HDR is more invasive and requires multiple sessions, allowing precise control over radiation delivery, while LDR is typically a one-time procedure with a long history of successful outcomes. These treatments differ from other options by focusing radiation internally, minimizing exposure to surrounding healthy tissues. ^{1 2 5 8 9}

Research Team

Ross Halperin, MD

Principal Investigator

British Columbia Cancer Agency Program Director

Eligibility Criteria

Men with intermediate risk prostate cancer who haven't had pelvic radiation, prostate surgery, chemotherapy for prostate cancer, or certain other prostate treatments. They should have a clinical stage T1c-T2b, PSA < 20 ng/ml, Gleason score < 8, and be in good physical condition (ECOG 0-1). Their tumor characteristics must meet specific criteria and they can't be eligible for just monitoring the cancer without treatment.

Inclusion Criteria

I am fully active or can carry out light work.

My prostate cancer is in an early stage, with low PSA and Gleason scores.

I have a specific type of prostate cancer that is not considered low risk, and I haven't started any hormone therapy.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I have had major surgery for prostate cancer.

I have had surgery or cryotherapy for prostate issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either low dose rate (LDR) or high dose rate (HDR) brachytherapy. LDR is delivered in a single procedure, while HDR is delivered in two procedures, two weeks apart.

2-4 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of urinary, bowel, and sexual side effects using the EPIC questionnaire.

3 years

Every 3 months for 1 year, then every 6 months to 3 years

Long-term Follow-up

Participants continue to be monitored for biochemical outcomes and long-term toxicity, with PSA recorded every 6 months to 5 years and then annually to 10 years.

10 years

Treatment Details

Interventions

• High Dose Rate Prostate Brachytherapy
• Low Dose Rate Prostate Brachytherapy

Trial Overview The trial is comparing two types of internal radiation therapy: Low Dose Rate (LDR) brachytherapy involving permanent radioactive seeds and High Dose Rate (HDR) temporary brachytherapy. Participants will be randomly assigned to one of these treatments to see which is more effective at treating intermediate risk prostate cancer.

Participant Groups

Group I: High dose rate brachytherapy Experimental Treatment 1 Intervention

Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Group II: Low dose rate brachytherapy Active Control 1 Intervention

Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Findings from Research

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]

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 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]

Low-dose-rate (LDR) brachytherapy is a one-time procedure with a long history of excellent outcomes and low side effects, making it the gold standard for low-risk prostate cancer patients.

High-dose-rate (HDR) brachytherapy, while more invasive and requiring multiple sessions, offers better control over dosimetry, allowing for safe dose escalation, but lacks extensive long-term data compared to LDR. Both techniques show equivalent effectiveness in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose-rate or high-dose-rate brachytherapy in treatment of prostate cancer - between options. Skowronek, J.[2022]

High-dose-rate (HDR) brachytherapy is increasingly used for treating prostate cancer, allowing for large doses to be delivered directly to the tumor while minimizing damage to surrounding healthy tissues.

This technique is particularly effective for high-risk prostate cancer patients when combined with external beam radiotherapy, leveraging the unique sensitivity of prostate tumors to higher radiation doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HDR Brachytherapy in the Management of High-Risk Prostate Cancer. Masson, S., Persad, R., Bahl, A.[2021]

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

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]

3. 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]

4. 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]

5. Poland pubmed.ncbi.nlm.nih.gov

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

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

Dose to the dominant intraprostatic lesion using HDR vs. LDR monotherapy: A Phase II randomized trial. [2019]

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. Poland pubmed.ncbi.nlm.nih.gov

Low-dose-rate or high-dose-rate brachytherapy in treatment of prostate cancer - between options. [2022]

9. Egypt pubmed.ncbi.nlm.nih.gov

HDR Brachytherapy in the Management of High-Risk Prostate Cancer. [2021]