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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of brachytherapy boosts—High Dose Rate (HDR) and Low Dose Rate (LDR)—to determine which is more effective for treating prostate cancer. The researchers aim to discover if the HDR boost can provide the same or better outcomes in preventing cancer recurrence while being gentler on the body and enhancing quality of life compared to the LDR boost. Men diagnosed with intermediate to high-risk prostate cancer who meet specific criteria, such as a high PSA level or a particular tumor stage, may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve future prostate cancer treatments.

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.

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

Research has shown that both High Dose Rate (HDR) and Low Dose Rate (LDR) brachytherapy are generally safe for treating prostate cancer. Studies indicate that patients tolerate HDR brachytherapy well. It can be used alone or with other treatments and often results in a good quality of life with manageable side effects.

Similarly, LDR brachytherapy is safe, with side effects that are usually mild and temporary. It is a common method for delivering radiation directly to the prostate.

Overall, both treatments are considered safe options, with studies supporting their use in prostate cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HDR (High-Dose Rate) and LDR (Low-Dose Rate) brachytherapy for prostate cancer because they offer unique delivery methods compared to standard treatments like surgery or external beam radiation alone. HDR brachytherapy delivers a precise, high dose of radiation directly to the prostate in a short period, potentially reducing treatment time and sparing healthy tissue. On the other hand, LDR brachytherapy uses radioactive seeds implanted in the prostate, providing a continuous, low dose of radiation over a longer period. These techniques aim to enhance treatment effectiveness while minimizing side effects, which is why they are generating interest in the medical community.

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 effectively treat this condition. Participants in the HDR arm will receive an HDR implant to deliver 15 Gy to the prostate before starting the external beam component of their treatment. Meanwhile, participants in the LDR arm will receive a permanent seed radioactive implant using iodine-125 seeds after completing 46 Gy of external beam radiotherapy. HDR brachytherapy, especially when combined with external radiation, has high success rates, with over 90% of patients remaining cancer-free. Both HDR and LDR brachytherapy have an 85% success rate in preventing the return of prostate-specific antigen (PSA) markers, which can indicate cancer. Studies suggest that HDR may lead to a better quality of life and fewer side effects compared to LDR. In summary, both treatments are effective, but HDR might offer additional benefits in terms of side effects and quality of life. ^{3 4 5 6 7}

Who Is on the Research Team?

Juanita M Crook, MD

Principal Investigator

British Columbia Cancer Agency

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

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 ...

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

High-Dose-Rate Brachytherapy Boost for Prostate Cancer a single high-dose-rate (HDR) of 15 Gy combined with external radiation therapy of 40 to 50 Gy results in disease-free survival of over 90% for intermediate- ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

5. 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 ... HDR and LDR boost both appear to be highly effective for the treatment of unfavorable risk prostate cancer, with 85% biochemical cure (i.e., PSA ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38160102/

Safety of high-dose rate (HDR) brachytherapy for patients ... Conclusions: HDR-BT is a safe treatment for patients with prostate cancer who previously received RT for rectal cancer. Further studies are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000138

Effectiveness, toxicity and impact on quality of life of high ... High-dose-rate brachytherapy is an option for prostate cancer patients. •. Two fractions of high-dose-rate brachytherapy as monotherpy appear to be safe. •.