Brachytherapy + SBRT for Prostate Cancer

Overseen By Heather D Mittelstedt, RN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Large prostate, Inflammatory bowel, Recent surgery, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for prostate cancer by combining two types of radiation therapy: High Dose Brachytherapy and Stereostatic Body Radiation Therapy (SBRT). Researchers aim to determine if this combination is safe and effective for individuals with more advanced, yet localized, prostate cancer. The trial seeks participants diagnosed with a higher-risk form of prostate cancer who have not yet received other treatments. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could lead to new treatment options for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combination of HDR Brachytherapy and SBRT is safe for prostate cancer treatment?

Research shows that high-dose-rate (HDR) brachytherapy and stereotactic body radiation therapy (SBRT) are generally well-tolerated treatments for prostate cancer. In past studies, patients received these treatments with minimal harm to nearby organs. This allows the cancer to receive a strong dose of radiation while mostly protecting the surrounding healthy tissues.

Reports indicate that patients who underwent HDR brachytherapy or SBRT experienced similar success in controlling the disease over several years. This suggests both treatments are effective and manageable. HDR brachytherapy has been used successfully for prostate cancer, demonstrating its relative safety.

While no treatment is without risk, these therapies have a history of being well-tolerated. However, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for prostate cancer, such as surgery or conventional radiation therapy, the combination of high dose rate (HDR) brachytherapy and stereotactic body radiation therapy (SBRT) offers a unique approach that targets the cancer more precisely. HDR brachytherapy involves placing radiation sources directly inside or next to the tumor, providing a high dose in a very specific area, which minimizes damage to surrounding healthy tissue. Meanwhile, SBRT delivers high doses of radiation from outside the body but with pinpoint accuracy. Researchers are excited about this combination because it aims to enhance treatment effectiveness while potentially reducing side effects and treatment time.

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

This trial will evaluate the combination of high-dose-rate (HDR) brachytherapy and stereotactic body radiation therapy (SBRT) for treating prostate cancer. Research has shown that using these treatments together can be effective. Studies have found that patients with high or very high-risk prostate cancer who received either HDR or SBRT experienced similar outcomes over 3 to 5 years. One study found that using SBRT with doses similar to HDR is both safe and effective, delivering precise, high doses of radiation directly to the prostate. Early findings suggest that these combined treatments can control cancer growth and reduce the chance of recurrence. Overall, evidence supports that this approach could effectively treat prostate cancer by intensely targeting the tumor while protecting healthy tissues. ^{2 3 4 6 7}

Who Is on the Research Team?

Michael J Baine, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

Men over 19 with intermediate or high-risk prostate cancer that hasn't spread, who haven't had previous treatments, and are expected to live more than 10 years. They should have a good performance status (able to carry out daily activities), no large prostate issues, and be able to undergo anesthesia.

Inclusion Criteria

My risk of cancer spread to lymph nodes is 15% or higher.

I have not received any treatment for my condition yet.

My scans show no cancer spread to lymph nodes or distant parts.

Exclusion Criteria

American Urological Association Urinary Symptom Score (AUA score) ≥ 15

My doctor says I cannot have radiation therapy due to certain health risks.

Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HDR brachytherapy to the prostate followed by SBRT to the prostate and pelvic lymph nodes

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of toxicity and biochemical progression-free survival

28 months

Regular visits at months 4, 10, 16, 22, and 28 post-SBRT

Long-term follow-up

Participants are assessed for chronic toxicity, local control, locoregional control, distant metastasis, and overall survival

Up to 28 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Brachytherapy
• Stereostatic Body Radiation Therapy

Trial Overview This trial tests combining Stereostatic Body Radiation Therapy (SBRT) for the whole prostate and nearby lymph nodes with High Dose Brachytherapy (HDR) directly in the prostate. It aims to assess safety and effectiveness in treating unfavorable-intermediate risk or higher localized prostate cancer.

How Is the Trial Designed?

Group I: High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment Experimental Treatment 2 Interventions

High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.

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

Approved in United States as High Dose Rate Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer

Approved in European Union as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in Canada as High Dose Rate Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

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) as a boost after external-beam radiotherapy shows promising biochemical control rates for intermediate and high-risk prostate cancer, with 5-year rates of 90% for biochemical control and 83% for recurrence-free survival.

The treatment was well-tolerated, with no severe acute gastrointestinal or genitourinary toxicities reported, indicating that SBRT could be a safe alternative for patients who are not candidates for high dose rate brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of hypofractionated stereotactic body radiotherapy boost for intermediate and high-risk prostate cancer. Anwar, M., Weinberg, V., Seymour, Z., et al.[2022]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

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 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 clinical trial involving 42 men with intermediate-risk prostate cancer, a treatment combining a single 15 Gy HDR brachytherapy boost with a five-fraction external beam radiation therapy (EBRT) resulted in a high biochemical disease-free survival rate of 95.5% after a median follow-up of 36 months.

The treatment demonstrated low toxicity, with only one case of acute Grade 3 gastrointestinal and genitourinary toxicity, and no significant differences in health-related quality of life across urinary, bowel, or sexual domains, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. Den, RB., Greenspan, J., Doyle, LA., et al.[2023]

High-dose-rate brachytherapy (HDR BRT) is gaining popularity as a treatment for prostate cancer, showing promise in both monotherapy and in combination with external beam radiation therapy (EBRT).

Long-term data indicates that HDR BRT provides effective oncologic outcomes while maintaining a manageable toxicity profile, supporting its use in various clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy for prostate cancer: Rationale, current applications, and clinical outcome. Strouthos, I., Karagiannis, E., Zamboglou, N., et al.[2022]

High-dose-rate brachytherapy (HDR-BT) delivers a significantly higher dose to the planning target volume (PTV) compared to both robotic and conventional stereotactic body radiotherapy (SBRT), indicating its potential for more effective treatment of prostate cancer.

HDR-BT results in lower radiation exposure to the bladder and rectum than SBRT, which may reduce the risk of side effects, although it does expose the urethra to a higher dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment planning comparison of high-dose-rate brachytherapy vs. robotic and conventional stereotactic body radiotherapy for ultrahypofractionated treatment of prostate cancer. Yoshioka, Y., Sasamura, K., Ito, M., et al.[2023]

In a study of 34 high-risk prostate cancer patients, stereotactic body radiotherapy (SBRT) as a boost after pelvic radiotherapy showed excellent biochemical control, with none of the patients experiencing a relapse over an average follow-up of 41.2 months.

The treatment was associated with manageable side effects, with 14% experiencing grade 2 or higher gastrointestinal toxicity and 29% experiencing genitourinary toxicity, but no severe late toxicities were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a boost after external beam radiotherapy for high-risk prostate cancer patients. Turna, M., Akboru, H., Ermis, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9535414/

A comparison between high dose rate brachytherapy and ... Our results indicate similar 3- and 5-year BRFS in patients with high/very high-risk prostate cancer who received HDRB or SBRT boost.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04870567

HDR Brachytherapy vs SABR in Early-intermediate ... Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher ...

3. mdpi.com mdpi.com/2072-6694/12/12/3606

Ablative Radiotherapy in Prostate Cancer: Stereotactic ... Hoskin et al. reported favorable results in a cohort of patients who received 19–20 Gy in a single fraction compared to two fractions of 13 Gy or three ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9373838/

High Dose “HDR-Like” Prostate SBRT: PSA 10-Year Results ... This HDR-like SBRT regimen prescribing 38 Gy/4 fractions but delivering much higher intraprostatic doses on a daily basis is safe and effective.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405631623000362

Treatment planning comparison of high-dose-rate ... This study was performed to compare clinically applied treatment plans for patients who had been treated using HDR-BT vs. conventional or robotic SBRT.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

High dose-rate brachytherapy in the treatment of prostate cancer High dose-rate (HDR) brachytherapy involves delivery of a high dose of radiation to the cancer with great sparing of surrounding organs at risk.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814021060916

and intermediate risk prostate cancer: High-dose-rate ... This study reported treatment outcomes for prostate cancer patients receiving ultra-hypofractionated radiotherapy using high dose-rate brachytherapy (HDR ...