SBRT vs LDR Brachytherapy for Prostate Cancer

Overseen By Eric Vigneault, MD, FRCPC

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: Metastatic disease, Gleason ≥ 4+3, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

208 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use alpha reductase inhibitors within two weeks of joining the trial, and no hormonal therapy is allowed.

What data supports the effectiveness of the treatment SBRT vs LDR Brachytherapy for Prostate Cancer?

Both low-dose-rate brachytherapy (LDR) and stereotactic body radiation therapy (SBRT) have shown good outcomes for treating low- and intermediate-risk prostate cancer, with studies indicating excellent long-term results and minimal side effects. Research suggests that these treatments provide similar rates of controlling the disease biochemically, meaning they are both effective in managing prostate cancer. ^{1 2 3 4 5}

Is SBRT or LDR Brachytherapy safe for treating prostate cancer?

Both SBRT (Stereotactic Body Radiation Therapy) and LDR Brachytherapy (Low-Dose-Rate Brachytherapy) have been shown to be generally safe for treating prostate cancer, with few serious side effects reported. Studies indicate that these treatments are well-tolerated, with minimal severe adverse effects, making them safe options for prostate cancer patients. ^{1 2 3 5 6}

How does the treatment SBRT vs LDR Brachytherapy for prostate cancer differ from other treatments?

SBRT (Stereotactic Body Radiation Therapy) and LDR Brachytherapy (Low-Dose Rate Brachytherapy) are unique in that they both offer targeted radiation treatments for prostate cancer, but they differ in delivery methods. SBRT is a non-invasive, external treatment that delivers high doses of radiation in fewer sessions, while LDR Brachytherapy involves implanting radioactive seeds directly into the prostate, providing continuous low-dose radiation over time. ^{1 2 4 7 8}

Research Team

Isabelle Thibault, MD, FRCPC

Principal Investigator

CHU de Québec-Université Laval

Eligibility Criteria

Men over 18 with low to favorable intermediate-risk prostate cancer, who are medically fit for brachytherapy and have not had hormonal therapy or certain other treatments. They must have a performance status of 0-1, an IPSS ≤ 20, no history of severe comorbidities that would interfere with the trial, and agree to fill out specific questionnaires.

Inclusion Criteria

All participants must submit a consent form before joining the study.

Patients must be able and ready to finish the EPIC-26, IPSS and SHIM surveys.

I was diagnosed with prostate cancer less than 8 months ago.

Exclusion Criteria

My prostate cancer has a Gleason score of 7 or higher.

I have had major surgery for prostate cancer or a TURP procedure.

I have had cancer before, but it was either skin cancer treated well or any cancer treated over 3 years ago with no signs of it now.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SBRT or LDRB treatment for prostate cancer

5 weeks

5 visits (in-person)

Follow-up

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

5 years

Regular visits at 1, 3, 6, 9, 12, 18, 24, 36 months, and yearly thereafter

Treatment Details

Interventions

• Low-Dose Rate Brachytherapy
• Stereotactic Body Radiation Therapy

Trial Overview This study compares two types of radiation therapy: SBRT (a precise external beam technique) versus LDRB (internal radiation using Iodine-125 seeds). It's designed to see which causes fewer urinary/gastrointestinal side effects and leads to better quality of life in patients with localized prostate cancer.

Participant Groups

Group I: Stereotactic Body Radiation Therapy to the prostate Experimental Treatment 1 Intervention

Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.

Group II: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant Active Control 1 Intervention

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.

Low-Dose Rate Brachytherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Low-Dose Rate Brachytherapy for:

• Prostate cancer
• Localized prostate cancer

Approved in United States as Low-Dose Rate Brachytherapy for:

• Prostate cancer
• Localized prostate cancer

Approved in Canada as Low-Dose Rate Brachytherapy for:

• Prostate cancer
• Localized prostate cancer

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Findings from Research

In a study involving 337 patients with low- and intermediate-risk prostate cancer, both low-dose-rate (LDR) brachytherapy and stereotactic body radiation therapy (SBRT) showed similar rates of biochemical control at 5 years, with LDR at 91.6% and SBRT at 97.6%.

LDR was associated with higher short-term urinary symptoms and lower rates of late gastrointestinal toxicity compared to SBRT, indicating that while both treatments are effective, LDR may have a more favorable gastrointestinal safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical Control and Toxicity Outcomes of Stereotactic Body Radiation Therapy Versus Low-Dose-Rate Brachytherapy in the Treatment of Low- and Intermediate-Risk Prostate Cancer. Gogineni, E., Rana, Z., Soberman, D., et al.[2021]

In a study of 195 patients treated with low-dose rate brachytherapy (LDR-BT) for low-risk prostate cancer, the five-year biochemical failure-free survival (BFFS) rate was an impressive 95.7%.

The study found that the dose delivered to the prostate (D90%) was significantly linked to BFFS, indicating that a dose range of 170-180 Gy leads to excellent treatment outcomes with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose rate brachytherapy with I-125 seeds has an excellent 5-year outcome with few side effects in patients with low-risk prostate cancer. Rasmusson, E., Gunnlaugsson, A., Kjellén, E., et al.[2022]

In a study of 201 patients treated with low-dose-rate (LDR) brachytherapy for localized prostate cancer, there was a significant and persistent decline in prostate-specific antigen (PSA) levels over time, indicating effective cancer control.

After 10 years of follow-up, only 9 patients experienced tumor recurrence, and while some urinary symptoms were noted initially, they significantly decreased after 18 months, suggesting that LDR brachytherapy is both safe and effective with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. D'hulst, P., Mattelaer, P., Darras, J., et al.[2022]

In a study of 340 patients with localized prostate cancer treated with iodine-125 low-dose-rate brachytherapy (LDR-BT), the 5-year and 10-year biochemical recurrence-free survival (BRFS) rates were very high at 99.4% and 95.3%, respectively, indicating the long-term efficacy of this treatment.

Younger patients (aged ≤63 years) had a higher risk of biochemical recurrence, but the overall incidence of secondary cancers post-treatment was low (1.8%), suggesting that while risks exist, LDR-BT remains a viable option for younger patients with localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient age as a predictive factor in biochemical recurrence following brachytherapy: Oncological outcomes at a single center. Takeuchi, S., Iinuma, K., Nakano, M., et al.[2023]

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]

Stereotactic ablative radiotherapy (SABR) is a safe and effective treatment for low and intermediate risk prostate cancer, with only a 2.25% failure rate observed in a study of 400 patients over a median follow-up of 15 months.

The treatment resulted in a significant decline in prostate-specific antigen (PSA) levels, with no severe late adverse effects reported, indicating that SABR could be considered for more advanced cases of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients Miszczyk, L., Namysł Kaletka, A., Napieralska, A., et al.[2020]

In a study of 79 prostate cancer patients treated with virtual HDR SBRT, the median PSA level dropped significantly from 5.6 ng/mL to 0.05 ng/mL after 5 years, indicating effective cancer control.

The treatment resulted in a high 5-year biochemical-relapse-free survival rate of 100% for low-risk and 92% for intermediate-risk patients, with manageable toxicity levels, including only 6% experiencing late grade 3 GU toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife SBRT for Localized Prostatic Carcinoma: 5-Year Disease-Free Survival and Toxicity Observations. Fuller, DB., Naitoh, J., Mardirossian, G.[2023]

Low-dose rate brachytherapy (LDR-BT) showed similar biochemical recurrence-free survival rates compared to radical prostatectomy (RP) after 5 years, indicating that both treatments are equally effective in preventing cancer recurrence in localized prostate cancer.

LDR-BT had a significant advantage over RP in terms of urinary incontinence (0% vs. 18% incidence), while RP was associated with more urinary irritation (80% vs. 4.5% incidence), highlighting the differing side effect profiles of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose rate brachytherapy for men with localized prostate cancer. Peinemann, F., Grouven, U., Hemkens, LG., et al.[2022]

References

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

Biochemical Control and Toxicity Outcomes of Stereotactic Body Radiation Therapy Versus Low-Dose-Rate Brachytherapy in the Treatment of Low- and Intermediate-Risk Prostate Cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Low-dose rate brachytherapy with I-125 seeds has an excellent 5-year outcome with few side effects in patients with low-risk prostate cancer. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Patient age as a predictive factor in biochemical recurrence following brachytherapy: Oncological outcomes at a single center. [2023]

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

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

6. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife SBRT for Localized Prostatic Carcinoma: 5-Year Disease-Free Survival and Toxicity Observations. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Low-dose rate brachytherapy for men with localized prostate cancer. [2022]