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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two radiation treatments for men with intermediate-risk prostate cancer. One treatment uses low-dose rate (LDR) brachytherapy, which involves placing small radioactive seeds in the prostate in a single procedure. The other uses high-dose rate (HDR) brachytherapy, involving two procedures with temporary radiation. Men with prostate cancer who haven't undergone certain surgeries or treatments and aren't candidates for active surveillance might be suitable. Participants may also have their cancer's aggressiveness assessed through a special gene profile. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both high dose rate (HDR) and low dose rate (LDR) brachytherapy for prostate cancer are safe options.

For HDR brachytherapy, studies have found it safe when used alone, particularly for patients with low- and intermediate-risk prostate cancer. Patients typically handle the treatment well. While some side effects can occur, they are often manageable.

LDR brachytherapy also demonstrates good safety results. Research indicates it offers high survival rates, with most studies showing survival rates over 95% for prostate cancer. This treatment is known for manageable side effects, making it a reliable choice for many patients.

Both treatments have a strong safety record, with studies reporting low levels of side effects. This suggests they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about high dose rate (HDR) and low dose rate (LDR) brachytherapy for prostate cancer because these treatments offer unique delivery methods compared to traditional external beam radiation therapy. HDR brachytherapy involves delivering radiation in two quick procedures spaced two weeks apart, which means patients can avoid the inconvenience of frequent hospital visits. Meanwhile, LDR brachytherapy is completed in a single session, with just one follow-up imaging visit to ensure implant quality. Both methods aim to precisely target the prostate, potentially reducing side effects and improving treatment precision compared to standard options.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare high dose rate (HDR) and low dose rate (LDR) brachytherapy for prostate cancer. Research has shown that both HDR and LDR brachytherapy are effective treatments. Participants in one arm of this trial will receive HDR brachytherapy, which has been found to control the disease well; studies have shown that 97% of patients do not experience cancer recurrence in the treated area. Participants in another arm will receive LDR brachytherapy, which also yields good results; studies indicate it can prevent cancer progression in 75% to 95% of patients with an intermediate risk of the disease. Over five and eight years, there is no major difference in the success of HDR and LDR treatments, making both strong options for treating prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Ross Halperin, MD

Principal Investigator

British Columbia Cancer Agency Program Director

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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thegreenjournal.com

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The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose ...