Brachytherapy + Stereotactic Radiotherapy for Prostate Cancer

(fBTsRT Trial)

Recruiting at 2 trial locations

Overseen By Mom Phat

Age: Any Age

Sex: Male

Trial Phase: Phase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prostate cancer treatment using a combination of two radiation therapies: Focal HDR Brachytherapy (a form of internal radiation) and Stereotactic Radiotherapy. Researchers aim to determine if this method better reduces urinary problems compared to the usual treatment. The trial seeks men diagnosed with prostate cancer who have planned radiation treatments and less than half of their prostate affected by the disease. Participants should be in good general health with a manageable number of other health issues. The study aims to improve quality of life by minimizing treatment side effects. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in prostate cancer care.

Do I need to stop taking my current medications for this trial?

The trial protocol 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 stereotactic radiotherapy, a precise type of radiation treatment, is generally considered safe for treating prostate cancer. One study found that patients who received this treatment did not experience a significant increase in major side effects over time, indicating it is well-tolerated. Another study found that its success rates are similar to other therapies, demonstrating effectiveness without adding extra risks.

For focal high-dose-rate (HDR) brachytherapy, which involves placing radiation inside the body, studies suggest it is safe. Specifically, one study showed that HDR brachytherapy is effective for patients with intermediate-risk prostate cancer, achieving high success in controlling the disease. Another study found that over 90% of patients remained disease-free, with no major safety concerns reported.

Both treatments have been used in other situations and have a strong safety record, suggesting they are likely well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining brachytherapy with stereotactic radiotherapy for prostate cancer because it offers a potentially more precise and powerful treatment than traditional methods. While standard treatments like external beam radiation therapy often require many sessions over several weeks, this approach uses highly focused radiation delivered in fewer sessions. This precision aims to target the tumor more effectively while sparing surrounding healthy tissue, potentially reducing side effects and improving recovery times.

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

This trial will compare focal HDR brachytherapy with stereotactic radiotherapy for prostate cancer. Research has shown that focal HDR brachytherapy effectively controls prostate cancer. One study found that more than 90% of men with intermediate-risk prostate cancer remained disease-free when this treatment was combined with external radiation. Another analysis reported that focal HDR brachytherapy is well tolerated and helps control prostate-specific antigen (PSA) levels.

For stereotactic radiotherapy, studies have shown it works as well as brachytherapy. Research found no significant difference in long-term cancer outcomes, indicating it is a reliable treatment option. Another report confirmed that stereotactic body radiotherapy (SBRT) did not increase the risk of cancer returning, making it a promising treatment for some prostate cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer who are planning to receive HDR brachytherapy boost alongside external beam radiotherapy. They should be in good physical condition (ECOG 0-1), have a low risk of other health issues (Charlson Comorbidity Index ≤ 4), and have visible disease in less than half of the prostate gland that matches biopsy results.

Inclusion Criteria

My prostate cancer affects less than half of my prostate, as shown by imaging and confirmed by biopsy.

I have prostate cancer and am scheduled for a specific radiation treatment aimed at curing it.

I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal HDR brachytherapy boost (15Gy) to stereotactic radiotherapy (35Gy/5)

5 weeks

Follow-up

Participants are monitored for urinary toxicity and quality of life using ePRO (EPIC-26)

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Focal HDR Brachytherapy
• Stereotactic Radiotherapy

Trial Overview The study is testing if combining focal High Dose Rate (HDR) Brachytherapy Boost with Stereotactic Radiotherapy (sRT) leads to better quality of life by reducing urinary irritation compared to standard treatments for prostate cancer.

Stereotactic Radiotherapy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy (SBRT) for:

• Early-stage lung cancer
• Primary lung tumors
• Metastatic lung tumors
• Tumors in the spine, liver, neck, lymph nodes, and soft tissues

Approved in European Union as Stereotactic Body Radiation Therapy (SBRT) for:

• Early-stage lung cancer
• Primary lung tumors
• Metastatic lung tumors
• Tumors in the spine, liver, neck, lymph nodes, and soft tissues

Approved in Japan as Stereotactic Body Radiation Therapy (SBRT) for:

• Early-stage lung cancer
• Primary lung tumors
• Metastatic lung tumors
• Tumors in the spine, liver, neck, lymph nodes, and soft tissues

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed similar 5-year survival rates (90.8% for SBRT vs. 88.1% for IMRT) and comparable freedom from biochemical failure (FFBF) rates, indicating its efficacy is on par with intensity-modulated radiation therapy (IMRT).

Both treatment methods had low toxicity, with no severe (grade 3 or higher) side effects reported, suggesting that SBRT is a safe alternative that offers the benefits of shorter treatment duration and lower costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. Oliai, C., Bernetich, M., Brady, L., et al.[2022]

In a study of 259 patients with low- or intermediate-risk prostate cancer, a novel 4-fraction stereotactic body radiation therapy (SBRT) regimen showed a 100% biochemical recurrence-free rate for low-risk patients and an 88.5% rate for intermediate-risk patients after 5 years, indicating high efficacy.

The treatment had low toxicity rates, with only 12.4% experiencing grade 2 urinary toxicity and no significant gastrointestinal side effects, while quality of life scores returned to baseline by 6 months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 Multicenter Trial of Heterogeneous-dosing Stereotactic Body Radiotherapy for Low- and Intermediate-risk Prostate Cancer: 5-year Outcomes. Fuller, DB., Falchook, AD., Crabtree, T., et al.[2019]

A study involving 803 patients analyzed the quality of life (QOL) impacts of SBRT, IMRT, and brachytherapy for localized prostate cancer, showing that all treatments resulted in good QOL two years post-treatment.

SBRT demonstrated similar outcomes to IMRT in urinary and sexual domains, but showed a significant improvement in bowel symptoms compared to brachytherapy, suggesting it may be a safer option with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. Evans, JR., Zhao, S., Daignault, S., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

In a study of 38 prostate cancer patients treated with stereotactic body radiotherapy (SBRT), the treatment was well tolerated, with only 42% experiencing mild acute gastrourinary toxicity and no severe acute side effects reported.

The median PSA nadir for patients receiving SBRT boost was 0.10 ng/mL, indicating effective treatment outcomes comparable to those achieved with HDR brachytherapy, suggesting SBRT could be a viable alternative for prostate cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as monotherapy or post-external beam radiotherapy boost for prostate cancer: technique, early toxicity, and PSA response. Jabbari, S., Weinberg, VK., Kaprealian, T., et al.[2018]

In a study of 26 patients with low- or intermediate-risk prostate adenocarcinoma, stereotactic body radiation therapy (SBRT) showed excellent biochemical control with no observed failures after a median follow-up of 59.5 months.

The treatment resulted in manageable late toxicity, with only 11.5% of patients experiencing significant genitourinary or gastrointestinal side effects, and patient-reported quality of life remained stable compared to pre-treatment levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. Maas, JA., Dobelbower, MC., Yang, ES., et al.[2023]

Stereotactic body radiotherapy (SBRT) for localized prostate cancer showed a 5-year biochemical relapse-free survival (bRFS) rate of 93% across 1100 patients, indicating its effectiveness as a treatment option.

The study found no significant differences in outcomes based on the use of androgen deprivation therapy or total radiation dose, suggesting that SBRT is a robust treatment regardless of these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. King, CR., Freeman, D., Kaplan, I., et al.[2022]

In a study of 551 low- and intermediate-risk prostate cancer patients treated with high-dose stereotactic body radiotherapy (SBRT), the treatment was well tolerated, with only 1.8% experiencing acute gastrointestinal toxicities and 10% experiencing acute genitourinary toxicities.

The 5-year cumulative incidence of prostate-specific antigen (PSA) failure was low at 2.1%, and 88% of patients who underwent biopsies after treatment showed no residual active disease, indicating effective tumor control with this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Tolerance and Tumor Control Outcomes with High-dose Ultrahypofractionated Radiation Therapy for Prostate Cancer. Zelefsky, MJ., Pinitpatcharalert, A., Kollmeier, M., et al.[2021]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

In a study of 108 prostate cancer patients treated with a combination of SBRT and IMRT, the 3-year biochemical control rates were excellent, achieving 100% for intermediate-risk and 89.8% for high-risk patients, indicating effective cancer management.

Patients experienced only transient declines in urinary and bowel function during treatment, with most recovering to near baseline levels by 2 years post-treatment, suggesting that this combined therapy is well tolerated and has minimal long-term impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-Modulated Radiation Therapy with Stereotactic Body Radiation Therapy Boost for Unfavorable Prostate Cancer: The Georgetown University Experience. Mercado, C., Kress, MA., Cyr, RA., et al.[2020]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

In a study of 101 patients with higher-risk localized prostate cancer, combining high-dose-rate (HDR) brachytherapy with stereotactic body radiation therapy (SBRT) resulted in a very low incidence of severe toxicities, with no grade ≥3 toxicities observed and only 0.99% experiencing grade 2 gastrointestinal issues.

The treatment showed promising efficacy, with a 2-year biochemical relapse-free survival rate of 97%, indicating strong cancer control outcomes alongside a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. Gorovets, D., Hopkins, M., Kollmeier, M., et al.[2021]

In a study of 174 hormone-naïve patients with localized prostate cancer treated with stereotactic body radiation therapy (SBRT), significant urinary symptoms were reported more frequently than bowel symptoms, with 51.6% of patients experiencing a clinically significant decline in urinary scores at 12 months.

The study indicates that while urinary and bowel symptoms initially increased after treatment, the proportion of patients reporting significant declines in these symptoms decreased from 12 to 36 months, suggesting potential late improvements in quality of life following SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? Woo, JA., Chen, LN., Wang, H., et al.[2020]

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. 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- ...

3. 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 ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40789422/

Updated results of MR-assisted focal salvage HDR ... Conclusion: Our toxicity and PSA failure-free results suggest that focal gland salvage HDR brachytherapy is well tolerated and effective. Clinicaltrials: gov ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03312972

Focal Salvage HDR Brachytherapy for Locally Recurrent ... This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for ...