HDR Brachytherapy for Prostate Cancer

(BrachyTRACKS Trial)

Overseen By Juanita M Crook, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Blood thinners

Disqualifiers: Prior prostate surgery, Prior chemotherapy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores high dose rate (HDR) brachytherapy for prostate cancer. The researchers aim to understand how HDR brachytherapy affects the body by studying changes in cancer cells and the immune system. This information might help doctors determine the optimal dose. Men with localized prostate cancer that hasn't spread but requires treatment might be suitable for this study. Participants should not have undergone major prostate surgery or radiation and must be comfortable with MRI scans and anesthesia.

As a Phase 2 trial, this research measures HDR brachytherapy's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that patients on blood thinners which cannot be stopped for 24 hours are excluded. It also states that no androgen deprivation therapy (ADT) is allowed.

What prior data suggests that HDR brachytherapy is safe for prostate cancer patients?

Research has shown that high dose rate (HDR) brachytherapy safely treats prostate cancer. Studies have found that HDR brachytherapy effectively delivers high doses of radiation directly to the prostate while protecting nearby organs, reducing unwanted side effects.

Patients in previous studies demonstrated that HDR brachytherapy, when used alone, is well-tolerated. It works especially well for those with intermediate-risk prostate cancer. Most patients experience manageable side effects, such as temporary urinary issues or discomfort, but serious complications are rare.

Overall, HDR brachytherapy has a strong safety record in treating prostate cancer, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

High dose rate (HDR) prostate brachytherapy is unique because it delivers targeted radiation directly to the prostate, which is different from traditional external beam radiation that affects a larger area. This precise approach helps to minimize damage to surrounding tissues, potentially reducing side effects. Additionally, HDR brachytherapy is delivered in just two outpatient procedures under anesthesia, spaced 1-2 weeks apart, making it a less time-consuming option compared to some current treatments that require more frequent sessions. Researchers are excited about HDR brachytherapy because it combines the effectiveness of high-dose radiation with the convenience of fewer treatment visits.

What evidence suggests that HDR brachytherapy is effective for prostate cancer?

Research has shown that high dose rate (HDR) brachytherapy, the treatment under study in this trial, effectively treats localized prostate cancer. Studies indicate it provides strong disease control for men with this condition. Specifically, using HDR brachytherapy alone has proven safe and effective for patients with intermediate-risk prostate cancer. When combined with external radiation therapy, more than 90% of patients remain disease-free. This treatment delivers a high dose of radiation directly to the prostate, helping to control and shrink the cancer. Overall, HDR brachytherapy is widely considered an effective treatment option for prostate cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Juanita M Crook, MD

Principal Investigator

Radiation Oncologist

Are You a Good Fit for This Trial?

This trial is for individuals with localized prostate cancer who are suitable candidates for a type of radiation therapy called High Dose Rate (HDR) brachytherapy. Specific eligibility details aren't provided, but typically participants would need to meet certain health standards and not have advanced or metastatic disease.

Inclusion Criteria

My prostate cancer is at an early stage, with specific PSA and Gleason scores.

My prostate cancer is not high-risk and I am expected to live 10 more years.

I am fully active or can carry out light work.

Exclusion Criteria

I cannot have general anesthesia, stop blood thinners for 24 hours, or have conditions like systemic sclerosis or inflammatory bowel disease.

I have had major surgery for prostate cancer.

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HDR brachytherapy in 2 fractions, 1-2 weeks apart, under anesthesia

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in gut microbiome, ctDNA, and immune response after treatment

4-6 weeks

Multiple assessments (in-person and virtual)

Long-term Follow-up

Participants are monitored for PSA levels and toxicity over several years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• High dose rate prostate brachytherapy

Trial Overview The study is testing HDR brachytherapy as a solo treatment for prostate cancer. It aims to understand how this therapy works by analyzing changes in tumor chemistry, immune response, gene expression, and other biological processes after treatment.

How Is the Trial Designed?

Group I: High dose rate prostate brachytherapy Experimental Treatment 1 Intervention

Radiation. High dose rate prostate brachytherapy is delivered under anesthesia in 2 procedures, 1-2 weeks apart. HDR brachytherapy is also accomplished as an out-patient.

High dose rate prostate brachytherapy is already approved in European Union, United States, Canada, United Kingdom for the following indications:

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in United States as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Approved in United Kingdom as HDR Brachytherapy for:

• Localized prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Vancouver Prostate Centre

Collaborator

Trials

10

Recruited

930+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

BC Cancer Foundation

Collaborator

Trials

20

Recruited

8,600+

Published Research Related to This Trial

In a study of 623 prostate cancer patients treated with high-dose-rate brachytherapy (HDR-BT) and external beam radiotherapy (EBRT), the 10-year prostate cancer-specific survival rates were excellent, reaching 100% for low-risk patients and 75% for very high-risk patients, indicating effective long-term tumor control.

While the treatment showed manageable levels of toxicity, with 28% experiencing grade 2 genitourinary (GU) toxicities and 12% experiencing gastrointestinal (GI) toxicities, the incidence of severe GU complications was notably higher in patients treated before 2003, highlighting the importance of dose constraints to minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two decades of high dose rate brachytherapy with external beam radiotherapy for prostate cancer. Åström, L., Grusell, E., Sandin, F., et al.[2018]

Single-fraction high-dose-rate (HDR) brachytherapy is a safe and effective treatment for early-stage prostate cancer, showing a low cumulative incidence of biochemical recurrence (BCR) at 2 years, particularly in low-risk patients (0% BCR).

In a study of 124 men with a median follow-up of 2.2 years, the overall BCR rate was 9.7%, with no prostate cancer-specific mortality and no severe genitourinary toxicity reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction brachytherapy as monotherapy for early-stage prostate cancer: The UCSF experience. Xu, MJ., Chen, KS., Chang, AJ., et al.[2020]

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]

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]

High-dose-rate (HDR) brachytherapy as a monotherapy in two fractions within one day is feasible for treating localized prostate cancer, including high-/very high-risk cases, with a median follow-up of 30.1 months showing minimal adverse events (AEs).

The treatment resulted in a high biochemical failure-free survival rate of 91.6% overall and 88.0% for high-/very high-risk patients, indicating effective disease control with acceptable safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early outcome of high-dose-rate Ir-192 brachytherapy as monotherapy in two fractions within 1 day for high-/very high-risk prostate cancer. Ashida, S., Yamasaki, I., Tamura, K., et al.[2020]

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]

A new therapy protocol combining high dose rate (HDR) brachytherapy and external beam radiation showed promising results in treating localized prostate cancer, with a 76.7% survival rate and 86.3% of patients remaining disease-free over a median follow-up of 6 years.

The study found that factors like lower tumor stage (T1-2), lower grade (G1-2), and normal PSA levels after treatment were associated with longer survival, highlighting the importance of PSA status as an independent prognostic factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High dosage brachytherapy and external irradiation of localized prostate carcinoma--results at the Kiel University Clinic]. Kovács, G., Galalae, R., Loch, T., et al.[2018]

High-dose-rate (HDR) brachytherapy is a safe and effective treatment for low-risk prostate cancer, with 45% of patients experiencing some form of acute toxicity, primarily grade 1 urinary toxicity, within three months post-treatment.

The study found that urinary toxicity was significantly linked to the dose received by the urethra, with patients receiving over 111.3% of the prescribed dose being four times more likely to experience urinary issues, highlighting the importance of careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. Cendales, R., Alwers, E., Cifuentes, J., et al.[2020]

High-dose-rate brachytherapy (HDR) combined with external beam radiotherapy shows high efficacy in treating prostate cancer, with relapse-free survival rates exceeding 90% for intermediate-risk patients and over 80% for high-risk patients, outperforming external beam radiotherapy alone.

A specific regimen of a single 15 Gy HDR boost along with 37.5 Gy of hypofractionated radiotherapy is well tolerated and can be completed in under 90 minutes, making it a quick and efficient treatment option for men with high and intermediate risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer: rationale and technique. Morton, GC.[2022]

High-dose-rate (HDR) brachytherapy is recognized as a potentially curative treatment for prostate cancer, with a consensus reached by an expert panel on its clinical applications based on a thorough review of recent literature.

The panel developed three clinical variants to guide the use of HDR brachytherapy, addressing different dosing and treatment indications for both primary and recurrent prostate cancer, which can help practitioners apply these guidelines effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. Hsu, IC., Yamada, Y., Assimos, DG., et al.[2022]

High-dose-rate (HDR) brachytherapy is a new and promising treatment for prostate cancer that offers potential benefits in radiation physics and radiobiology.

The article outlines the technique for using HDR brachytherapy as a standalone treatment, emphasizing its innovative approach, although clinical results are still developing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. Yoshioka, Y., Suzuki, O., Otani, Y., et al.[2021]

In a randomized phase II trial involving 170 patients with localized prostate cancer, HDR brachytherapy delivered in two fractions of 13.5 Gy resulted in significantly better 5-year biochemical disease-free survival (95%) compared to a single fraction of 19 Gy (73.5%).

The two-fraction treatment was well tolerated, with low rates of late rectal toxicity (1%) and manageable urinary toxicity (45% grade 2), indicating it is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Morton, G., McGuffin, M., Chung, HT., et al.[2021]

In a study of 148 prostate cancer patients treated with high-dose-rate (HDR) brachytherapy followed by intensity-modulated radiation therapy (IMRT), the treatment showed a high 4-year biochemical disease-free survival (bDFS) rate of 96.8% using the Phoenix criteria.

The treatment was well tolerated, with low rates of genitourinary (10%) and gastrointestinal (5%) toxicities, indicating that this combination therapy is both effective and safe for patients in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. Chen, WC., Tokita, KM., Ravera, J., et al.[2018]

High-dose rate brachytherapy (HDR-BT) using Ir-192 for prostate cancer patients at low risk of progression demonstrated a 100% disease-free survival rate over five years, indicating its efficacy as a monotherapy.

The treatment was safe, with only grade I toxic reactions reported in the genitourinary and gastrointestinal systems, and no severe adverse events, highlighting its potential to minimize harm to adjacent organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brachytherapy as monotherapy for prostate cancer with the use of temporary sources]. Solodky, VA., Pavlov, AY., Panshin, GA., et al.[2019]

Both single fraction 19Gy and two fractions of 13.5Gy HDR brachytherapy are safe and well tolerated for treating low and intermediate risk prostate cancer, with a median follow-up of 20 months showing manageable toxicity levels.

The two-fraction regimen resulted in higher rates of grade 2 erectile dysfunction and urinary symptoms compared to the single fraction, indicating that while both treatments are effective, the single fraction may have a better quality of life outcome in the first year post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Early toxicity and quality-of life results from a randomized phase II clinical trial of one fraction of 19Gy or two fractions of 13.5Gy. Morton, G., Chung, HT., McGuffin, M., et al.[2022]

Citations

1. 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 ...

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

Prostate high dose-rate brachytherapy as monotherapy for ... Multi-fraction high dose-rate brachytherapy (HDR) has emerged as a safe and effective monotherapy for patients with intermediate-risk prostate ...

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. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625003037

A Randomized Comparison of High-Dose-Rate and Low- ... This randomized trial compares HDR BT with LDR BT when used in combination with EBRT for unfavorable prostate cancer.

6. southcarolinablues.com southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/high-dose-rate-temporary-prostate-brachytherapy/

High-Dose Rate Temporary Prostate Brachytherapy In these series, median 5-year OS rates after salvage HDR brachytherapy ranged from 83% to 95.5% The evidence is insufficient to determine that the technology ...

7. prostatecanceruk.org prostatecanceruk.org/prostate-information-and-support/treatments/high-dose-rate-brachytherapy

High dose-rate (HDR) brachytherapy HDR brachytherapy gives an extra dose of radiotherapy to the prostate. You might hear this called a brachytherapy 'boost'. Having both external beam ...