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

Trial Summary

What is the purpose of this trial?

This is an observational single-center trial for patients with localized prostate cancer suitable for High Dose Rate (HDR) brachytherapy as monotherapy. This study takes a multi-omics approach to study the mechanism of action of HDR brachytherapy through metabolomics, immunological, transcriptomics, and spectroscopic profiling. The results of this study will clarify the optimal dose for HDR prostate brachytherapy by documenting the dose-response relationship seen in the changing tumor metabolites after HDR brachytherapy and investigate the immunogenicity of HDR brachytherapy.

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

Research shows that HDR brachytherapy, often combined with external beam radiation, is effective in treating localized prostate cancer, with a high percentage of patients remaining disease-free and having a good survival rate. Studies have demonstrated its safety and efficacy, especially in high-risk patients, and it has been used successfully as both a boost and a standalone treatment. ^{1 2 3 4 5}

Is HDR Brachytherapy safe for treating prostate cancer?

HDR Brachytherapy for prostate cancer has been shown to be generally safe, with most patients experiencing only mild side effects. Serious side effects are rare, and studies report that it minimizes harmful effects on nearby organs while effectively treating the cancer. ^{6 7 8 9 10}

How is HDR Brachytherapy different from other prostate cancer treatments?

HDR Brachytherapy for prostate cancer is unique because it delivers high doses of radiation directly to the prostate in a short period, minimizing exposure to surrounding healthy tissues. This method is particularly effective for prostate cancer due to the tumor's sensitivity to increased radiation doses, and it can be used alone or in combination with external beam radiotherapy for enhanced results. ^{11 12 13 14 15}

Research Team

Juanita M Crook, MD

Principal Investigator

Radiation Oncologist

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 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]

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[High dosage brachytherapy and external irradiation of localized prostate carcinoma--results at the Kiel University Clinic]. [2018]

2. France pubmed.ncbi.nlm.nih.gov

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

3. Ireland 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. [2021]

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

Single-fraction brachytherapy as monotherapy for early-stage prostate cancer: The UCSF experience. [2020]

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

Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. [2018]

6. 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]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Brachytherapy as monotherapy for prostate cancer with the use of temporary sources]. [2019]

8. England 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. [2020]

9. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. [2020]

10. Ireland 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. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

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

12. Ireland pubmed.ncbi.nlm.nih.gov

Two decades of high dose rate brachytherapy with external beam radiotherapy for prostate cancer. [2018]

13. Poland pubmed.ncbi.nlm.nih.gov

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

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

ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. [2022]

15. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. [2021]