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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two radiation treatments for men with low-risk or favorable intermediate-risk prostate cancer. It compares Stereotactic Body Radiation Therapy (SBRT) and Low-Dose Rate Brachytherapy (LDRB, also known as Low-Dose Rate Brachytherapy with Iodine-125 seed implant) to determine which causes fewer urinary and bowel side effects and offers a better quality of life. Men diagnosed with prostate cancer within the last eight months and who have mild symptoms might be suitable candidates. The results could guide future patients in selecting the best treatment option for their condition. As an unphased trial, this study allows patients to contribute to research that could enhance treatment choices for future prostate cancer patients.

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.

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

Research shows that Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating prostate cancer. Studies indicate that patients tolerate SBRT well, with a low risk of side effects. One study found that most patients who received SBRT experienced good results with only minor side effects. Another study showed that serious side effects were rare over five years.

Research also supports the safety of Low-Dose Rate Brachytherapy (LDRB), a common treatment for prostate cancer. LDRB involves placing tiny radioactive seeds inside the prostate to target cancer cells. This method has been used for a long time and is known for its effectiveness and safety.

Both treatments are generally well-tolerated, but patients should still consult their doctor to decide which is best. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer innovative approaches compared to traditional methods. Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers a high dose of radiation to the prostate in just five sessions, which can be more convenient and potentially just as effective as the longer conventional radiation schedules. On the other hand, Low-Dose Rate Brachytherapy involves implanting iodine-125 seeds directly into the prostate, providing a continuous, targeted radiation dose over time. Both methods aim to minimize damage to surrounding tissues while effectively targeting cancer cells, which is a significant advancement over standard radiation therapy options that often require more extended treatment periods and may affect more healthy tissue.

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

Research has shown that Stereotactic Body Radiation Therapy (SBRT), one of the treatments studied in this trial, effectively treats low and intermediate-risk prostate cancer. Studies have found that many patients remain disease-free after treatment, with survival rates of 92.9% at 1 and 2 years, and 92.3% at 5 years. Specifically, one study found that 95.7% of patients showed no signs of the disease after five years. SBRT is considered safe and generally well-tolerated by patients. Low-Dose Rate Brachytherapy (LDRB) is another treatment option in this trial that effectively targets radiation directly to the prostate. This trial aims to compare these two treatments to determine which one might lead to fewer side effects and a better quality of life for patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Isabelle Thibault, MD, FRCPC

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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]

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]

Citations

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Cyberknife Radioablation of Prostate Cancer Stereotactic ablative radiotherapy of low and intermediate risk prostate cancer patients is a safe, well-tolerated and effective treatment modality (2.25% of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405632424000209

Stereotactic body radiation therapy (SBRT) for prostate ... Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5,969 patients in seven international institutional datasets: α/β = 1.4 ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1270498/full

and intermediate-risk prostate cancer: clinical outcomes ... Results: The 1-, 2-, and 5-year DFS rates were 92.9%, 92.9%, and 92.3%, respectively, while the 1-, 2-, and 5-year bDFS rates were 100%, 100%, and 95.7%, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

5. redjournal.org redjournal.org/article/S0360-3016(24)03454-0/abstract

Stereotactic Body Radiation Therapy for Prostate Cancer is ... Stereotactic Body Radiation Therapy for Prostate Cancer is Getting Mature: 10-Year Outcomes From 3 Prospective Trials. Constantinos Zamboglou, PhD.

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Long-term Outcomes of Stereotactic Body Radiotherapy for ... Comparative analysis of efficacy and safety of radiation treatment options for low- and intermediate-risk prostate cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625034388

CyberKnife Stereotactic Body Radiation Therapy (SBRT ... This study describes a novel, safe, and low-toxicity radiation protocol for men with intermediate and high-risk prostate cancer, demonstrating that simultaneous ...

8. uclahealth.org uclahealth.org/departments/radonc/research-technologies/innovation-technology/external-beam-radiation-therapy-ebrt/stereotactic-body-radiation-therapy-sbrt/sbrt-prostate-cancer

SBRT for Prostate Cancer - Radiation Oncology SBRT is considered a standard of care option for any patient with low through very-high risk prostate cancer who is considering radiation therapy.

9. cco.amegroups.org cco.amegroups.org/article/view/16080/html

Stereotactic body radiation therapy for prostate cancer—a ... A majority of the data thus far reporting the outcomes for patients undergoing prostate SBRT have received 35–36.25 Gy in 5 daily fractions, a dose that ...