Brachytherapy + Stereotactic Radiotherapy for Prostate Cancer

(fBTsRT Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

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.

What data supports the idea that Brachytherapy + Stereotactic Radiotherapy for Prostate Cancer is an effective treatment?

The available research shows that Brachytherapy combined with Stereotactic Radiotherapy is effective for treating prostate cancer. Studies have shown that this treatment can lead to favorable outcomes, such as controlling the tumor and maintaining a good quality of life for patients. For example, one study found that using Stereotactic Radiotherapy with a focused boost resulted in low rates of cancer returning and manageable side effects over five years. Another study highlighted that patients reported positive outcomes over three years after receiving this treatment. These findings suggest that this combination treatment is a promising option for managing prostate cancer. ^{1 2 3 4 5}

What safety data is available for Brachytherapy and Stereotactic Radiotherapy in prostate cancer treatment?

The safety of stereotactic body radiotherapy (SBRT) for localized prostate cancer is established through phase III trials, though specific data for node-positive cases is limited. Preliminary results for stereotactic ablative radiotherapy (SABR) in advanced prostate cancer are promising. A phase II trial validated the safety of SBRT with stringent dose constraints. Comparisons of SBRT with intensity-modulated radiation therapy (IMRT) show SBRT as a viable option with manageable toxicity. Patient-reported outcomes indicate concerns about SBRT toxicity compared to other treatments, but it remains an attractive option due to its short duration and cost. ^{6 7 8 9 10}

Is the treatment Stereotactic Radiotherapy promising for prostate cancer?

Yes, Stereotactic Radiotherapy is promising for prostate cancer because it is a non-invasive treatment that delivers precise radiation similar to other effective methods, with fewer side effects. It is also cost-effective and uses fewer resources, making it a valuable option in healthcare. ^{3 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? [2020]

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

Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Early Tolerance and Tumor Control Outcomes with High-dose Ultrahypofractionated Radiation Therapy for Prostate Cancer. [2021]

6. Germany 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

11. United States 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. [2018]

12. Netherlands 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. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Intensity-Modulated Radiation Therapy with Stereotactic Body Radiation Therapy Boost for Unfavorable Prostate Cancer: The Georgetown University Experience. [2020]

14. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]