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

Trial Summary

What is the purpose of this trial?

The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.

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 data supports the effectiveness of the treatment Brachytherapy + SBRT for Prostate Cancer?

Research shows that combining high-dose-rate (HDR) brachytherapy with stereotactic body radiation therapy (SBRT) can improve outcomes for patients with higher-risk prostate cancer, increasing the chance of being cancer-free after treatment. ^{1 2 3 4 5}

Is the combination of Brachytherapy and SBRT safe for prostate cancer treatment?

Research shows that both high-dose-rate (HDR) brachytherapy and stereotactic body radiotherapy (SBRT) are generally safe for treating prostate cancer, with studies reporting on their safety, quality, and outcomes. These treatments have been used as monotherapy or in combination with external beam radiotherapy, and they have shown manageable side effects and good safety profiles. ^{3 5 6 7 8}

How is the Brachytherapy + SBRT treatment for prostate cancer different from other treatments?

This treatment combines high-dose-rate brachytherapy (a method where radiation is placed inside or next to the area needing treatment) with stereotactic body radiation therapy (a precise, high-dose radiation treatment from outside the body), offering a unique approach that can deliver high radiation doses directly to the prostate cancer while minimizing exposure to surrounding tissues. ^{1 2 3 5 9}

Research Team

Michael J Baine, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

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.

Life expectancy of more than 10 years as estimated by the treating physician

Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. 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]

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

Outcomes of hypofractionated stereotactic body radiotherapy boost for intermediate and high-risk prostate cancer. [2022]

3. 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]

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

High-dose-rate brachytherapy for prostate cancer: Rationale, current applications, and clinical outcome. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a boost after external beam radiotherapy for high-risk prostate cancer patients. [2022]

8. United States 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. [2022]

9. Netherlands 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. [2023]