HDR Brachytherapy for Prostate Cancer

Overseen By Alejandro Berlin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Anti-coagulative therapy

Disqualifiers: Ulcerative colitis, Crohn's disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating early-stage prostate cancer by comparing two methods of delivering high dose rate (HDR) brachytherapy: one targets the whole prostate gland, and the other focuses specifically on the tumor area. The goal is to determine if the targeted approach can reduce side effects, such as urinary issues and sexual difficulties, while still effectively treating the cancer. Men with localized prostate cancer detected through advanced imaging and who experience minimal urinary symptoms might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more personalized treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-coagulative therapy (blood thinners), you may need to temporarily stop them during the brachytherapy treatment.

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

Research has shown that high-dose-rate (HDR) brachytherapy is generally safe for treating prostate cancer. Brachytherapy delivers radiation directly to a tumor. Studies have found that HDR brachytherapy, whether focused on specific tumor areas or applied to the entire prostate gland, is both safe and effective.

For targeted focal HDR brachytherapy, research indicates it is a safe option for treating localized prostate cancer. Patients often experience good results with fewer side effects, which can include urinary and sexual issues, but these are usually milder compared to other treatments.

Whole-gland HDR brachytherapy also has a strong safety record. Studies show it effectively controls cancer with a low risk of severe side effects. While HDR brachytherapy can cause some urinary and sexual discomfort, these effects are often manageable.

In summary, both targeted focal and whole-gland HDR brachytherapy are considered safe for treating prostate cancer, with proven effectiveness and manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HDR Brachytherapy for prostate cancer because it offers a more precise and potentially less invasive treatment option compared to traditional external beam radiation therapy. Unlike the standard approach, which typically targets the whole prostate, the targeted focal HDR Brachytherapy zeroes in on the tumor visible on MRI, sparing more of the healthy surrounding tissue. This precision could lead to fewer side effects and improve the quality of life for patients. Additionally, the whole-gland HDR Brachytherapy provides a comprehensive treatment option for cases where no specific tumor is visible on MRI, ensuring all potential cancerous tissue is addressed.

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

Research has shown that high dose rate (HDR) brachytherapy effectively treats localized prostate cancer. Studies indicate that HDR brachytherapy leads to high rates of disease control, with some patients having up to an 87% chance of survival after three years. In this trial, participants will receive either targeted focal HDR brachytherapy, which manages the disease well and may reduce side effects like urinary and sexual problems due to its precise targeting, or whole-gland HDR brachytherapy, which has proven effective, with long-term results showing it as a safe option for recurrent prostate cancer. Both methods aim to control cancer effectively while minimizing the impact on daily life. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

Men over 18 with early-stage, low to favorable intermediate-risk prostate cancer can join this study. They should be in good health (ECOG status 0-2), have a prostate size <80cc, and no history of severe rectal conditions or certain autoimmune diseases. No prior radiation or brachytherapy for the prostate is allowed, and they must not have any contraindications to MRI or anesthesia.

Inclusion Criteria

Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

No contraindications to MRI: Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI

Baseline IPSS <18

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HDR brachytherapy, either whole-gland or targeted focal therapy based on MRI findings

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life improvements after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Focal HDR Brachytherapy
• Whole-gland HDR Brachytherapy

Trial Overview The trial is testing two types of high dose rate (HDR) brachytherapy treatments for localized prostate cancer: one that targets the whole gland and another that focuses on specific areas identified by MRI. The goal is to see if focal treatment reduces side effects while maintaining effectiveness.

How Is the Trial Designed?

Group I: Tumour visible on MRI Experimental Treatment 1 Intervention

Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose

Group II: No tumour visible on MRI Active Control 1 Intervention

Whole-gland HDR Brachytherapy

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Focal high dose rate (HDR) brachytherapy for locally recurrent prostate cancer showed a biochemical progression-free survival rate of 63% at 2 years and 46% at 3 years among 50 patients, indicating its efficacy as a salvage treatment.

The treatment had acceptable toxicity levels, with no severe gastrointestinal toxicities and only a few cases of late grade 3 genitourinary issues, suggesting it is a relatively safe option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Dose Focal Salvage High Dose Rate Brachytherapy for Locally Recurrent Prostate Cancer. Chitmanee, P., Tsang, Y., Tharmalingam, H., et al.[2020]

Focal, multimodal image-guided high-dose-rate (HDR) brachytherapy was successfully used to treat two patients with locally recurrent prostate cancer after previous radiation therapy, showing promising results with significant declines in prostate-specific antigen (PSA) levels (83% and 59.3%).

No acute or late toxicities were reported in either patient, indicating that this treatment method is safe, but further evaluation in larger clinical trials is necessary to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction multimodal image guided focal salvage high-dose-rate brachytherapy for recurrent prostate cancer. Zamboglou, C., Rischke, HC., Meyer, PT., et al.[2020]

High-dose-rate (HDR) brachytherapy is an effective treatment for localized prostate cancer, allowing for precise dose delivery that improves patient outcomes and minimizes damage to surrounding healthy tissues.

The treatment exploits the unique characteristics of prostate cancer, such as its low α/β ratio, to enhance radiation sensitivity, making it a valuable option either alone or in combination with external beam therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HDR Prostate Brachytherapy. Crook, J., Marbán, M., Batchelar, D.[2020]

High-dose-rate (HDR) focal brachytherapy for prostate cancer significantly reduces radiation exposure to surrounding organs at risk compared to standard whole gland treatment, with the most substantial reductions observed when treating only one-sixth of the gland.

In a study involving five patients, the HDR focal treatment achieved target dose objectives while minimizing damage to the bladder, rectum, and urethra, indicating a promising approach to reduce potential side effects, although further research is needed to assess its clinical impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis. Banerjee, R., Park, SJ., Anderson, E., et al.[2018]

In a study of 26 men with low to intermediate risk prostate cancer, focal low dose-rate (LDR) brachytherapy showed a high rate of biochemical control, with 96.2% of patients free from biochemical failure after treatment.

The treatment had a favorable safety profile, with only 29.2% experiencing grade 2 urinary toxicities and 45.8% reporting erectile toxicities, all of which resolved by the last follow-up, and no severe toxicities reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. Anderson, E., Smyth, LML., O'Sullivan, R., et al.[2022]

High-dose-rate (HDR) brachytherapy as a monotherapy for localized prostate cancer showed excellent outcomes, with a 5-year overall survival rate of 98.7% and biochemical control rate of 96.7% among 77 patients followed for a median of 57 months.

The treatment had an acceptable safety profile, with no severe (Grade 3 or higher) acute toxicities and only 24.6% of patients experiencing mild (Grade 2) genitourinary acute toxicity, indicating that HDR brachytherapy is both effective and safe for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as a monotherapy for prostate cancer--Single-institution results of the extreme fractionation regimen. Kukiełka, AM., Dąbrowski, T., Walasek, T., et al.[2022]

Focal high-dose-rate brachytherapy in 50 selected patients with localized prostate cancer showed promising results, achieving a significant reduction in PSA levels from a mean of 6.9 ng/mL to 3 ng/mL at follow-up, indicating effective cancer control.

The treatment demonstrated a favorable safety profile, with no acute or late urinary retention, no rectal toxicity, and minimal impact on sexual function, suggesting it may be a less toxic alternative to conventional whole prostate brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal high-dose-rate brachytherapy for localized prostate cancer: toxicity and preliminary biochemical results. Prada, PJ., Cardenal, J., García Blanco, A., et al.[2022]

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]

Focal prostate brachytherapy has the potential to effectively target cancer while reducing radiation exposure to surrounding healthy organs, which may allow for future salvage treatments if needed.

The review of 9 dosimetric and 6 clinical studies indicates that focal brachytherapy results in less toxicity compared to traditional whole gland treatments, suggesting it could be a safer option for patients with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Focal Prostate Brachytherapy and the Future Implementation of Image-Guided Prostate HDR Brachytherapy Using MR-Ultrasound Fusion. Peach, MS., Trifiletti, DM., Libby, B.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025045955

Updated results of MR-assisted focal salvage HDR ... Our updated analysis of 59 patients undergoing focal salvage HDR brachytherapy showed a 36-month biochemical control rate of 54.4 % with encouragingly low ...

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 The rates of OS, MFS, and BPFS at 3 years are 87%, 92%, and 78%, respectively. These results, comparable to those reported in the literature, ...

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. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2025.1598726/full

High-dose-rate brachytherapy lowers travel burden for men ... HDR-BT monotherapy significantly reduces the travel burden compared with EBRT for localized prostate cancer, with minimal treatment-associated toxicity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930011/

Long-term outcomes of salvage high-dose-rate ... Salvage HDR-BT without ADT is a safe and effective treatment option for localized prostate cancer recurrence after definitive radiation therapy.