High-Dose-Rate Brachytherapy for Prostate Cancer

Overseen By Therese Smudzin

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Metastatic disease, Neuroendocrine carcinoma, TURP, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on 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 data supports the effectiveness of the treatment High-Dose-Rate Brachytherapy for prostate cancer?

High-Dose-Rate Brachytherapy is supported by a well-established body of literature as an effective treatment for localized prostate cancer, with evidence suggesting improved survival when used as a boost to external beam radiation therapy (EBRT). Additionally, there is growing experience and promising potential for its use as a standalone treatment. ^{1 2 3 4 5}

Is high-dose-rate brachytherapy safe for humans?

High-dose-rate brachytherapy has been shown to be safe for treating prostate cancer, with studies reporting on its safety and quality of life outcomes. ^{1 6 7 8 9}

How is high-dose-rate brachytherapy different from other prostate cancer treatments?

High-dose-rate brachytherapy for prostate cancer is unique because it delivers a highly targeted, intense dose of radiation directly to the prostate, often in combination with external beam radiotherapy, resulting in higher effectiveness and lower long-term side effects compared to external beam radiotherapy alone. This method allows for a quick treatment process, often completed in less than 90 minutes, and is particularly effective for patients with intermediate to high-risk prostate cancer. ^{1 10 11 12 13}

Research Team

Hong Zhang

Principal Investigator

University of Rochester Wilmot Cancer Center

Eligibility Criteria

This trial is for men over 18 with prostate cancer that has come back, seen on an AXUMIN PET scan, after previous treatments like radiation or brachytherapy. They must be fit for anesthesia, have a good performance status (KPS ≥ 70%), and no severe urinary issues (IPSS score <16). Men with bowel diseases, inability to understand English, neuroendocrine prostate cancer types, recent TURP surgery or evidence of cancer spread outside the prostate are not eligible.

Inclusion Criteria

I do not have a rectal fistula or fissure.

Ability to understand, and willingness to sign the written informed consent

I had a special scan within the last 3 months showing cancer recurrence in my prostate.

Exclusion Criteria

You are not able to have an MRI scan.

I had a prostate surgery within the last 6 months.

My prostate cancer has spread, as shown by a recent AXUMIN PET scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose-rate brachytherapy for prostate cancer recurrence, delivered in 2 fractions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring of PSA levels and adverse events

6 months

Treatment Details

Interventions

• High-Dose-Rate Brachytherapy

Trial Overview The study tests high-dose-rate (HDR) brachytherapy—a type of internal radiation therapy—on patients whose prostate cancer has returned within the gland only. The effectiveness of this targeted treatment will be evaluated in those who've had prior radiation therapy at least two years ago.

Participant Groups

Group I: Experimental: High-Dose-Rate prostate brachytherapy Experimental Treatment 1 Intervention

High-Dose-Rate brachytherapy, 2 fractions

High-Dose-Rate Brachytherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Head and neck cancers
• Sarcoma
• Melanoma

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Head and neck cancers
• Breast cancer
• Lung cancer

Approved in Canada as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Head and neck cancers
• Breast cancer

Approved in Japan as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Head and neck cancers

Approved in China as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer

Approved in Switzerland as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Head and neck cancers

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

High-dose-rate (HDR) brachytherapy is a new and promising treatment for prostate cancer that offers potential benefits in radiation physics and radiobiology.

The article outlines the technique for using HDR brachytherapy as a standalone treatment, emphasizing its innovative approach, although clinical results are still developing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. Yoshioka, Y., Suzuki, O., Otani, Y., et al.[2021]

High-dose-rate (HDR) brachytherapy is recognized as a potentially curative treatment for prostate cancer, with a consensus reached by an expert panel on its clinical applications based on a thorough review of recent literature.

The panel developed three clinical variants to guide the use of HDR brachytherapy, addressing different dosing and treatment indications for both primary and recurrent prostate cancer, which can help practitioners apply these guidelines effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. Hsu, IC., Yamada, Y., Assimos, DG., et al.[2022]

High-dose-rate (HDR) brachytherapy shows excellent biochemical control rates for localized prostate cancer, achieving 85-100% for low-risk, 81-100% for intermediate-risk, and 43-93% for high-risk cases, based on a comprehensive review of literature.

Severe toxicity from HDR brachytherapy is rare, with less than 5% of patients experiencing Grade 3 or higher side effects, highlighting its safety as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Yamada, Y., Rogers, L., Demanes, DJ., et al.[2022]

In a study of 507 men with intermediate- and high-risk prostate cancer, HDR brachytherapy showed high long-term effectiveness, with biochemical no evidence of disease (bNED) rates of 86.9% at 10 years for intermediate-risk and 56.1% for high-risk patients.

The incidence of urethral stricture significantly decreased from 28.9% before 2005 to 4.2% after implementing prevention strategies, indicating improved safety of the procedure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of high-dose-rate brachytherapy for intermediate- and high-risk prostate cancer with a median follow-up of 10 years. Yaxley, JW., Lah, K., Yaxley, JP., et al.[2018]

Patients with intermediate- to high-risk prostate cancer who received a high-dose-rate (HDR) brachytherapy boost along with 3D conformal radiotherapy (3DCRT) showed significantly better overall survival rates at 5, 10, and 15 years compared to those who received 3DCRT alone, with survival rates of 92%, 81%, and 67% versus 88%, 71%, and 53%, respectively.

The HDR boost group also demonstrated improved cause-specific survival rates, indicating that this treatment combination not only prolongs life but also effectively targets cancer progression, with cause-specific survival rates of 96%, 93%, and 87% for the HDR group compared to 95%, 88%, and 79% for the 3DCRT group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. Kent, AR., Matheson, B., Millar, JL.[2019]

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 involving 293 patients with intermediate and high-risk localized prostate cancer, a single high-dose-rate brachytherapy (HDR-BT) treatment of 19-20Gy showed comparable biochemical relapse-free survival rates (94% for 1×19Gy and 93% for 1×20Gy) to multi-fraction treatments (93% for 2×13Gy and 91% for 3×10.5Gy) over a median follow-up of up to 108 months.

The single-dose HDR-BT resulted in low rates of late genitourinary (GU) and gastrointestinal (GI) morbidity, with no grade-4 complications observed, indicating it is a safe and effective treatment option for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose high-dose-rate brachytherapy compared to two and three fractions for locally advanced prostate cancer. Hoskin, P., Rojas, A., Ostler, P., et al.[2022]

High-dose-rate (HDR) brachytherapy for early-stage prostate cancer showed excellent outcomes, with a 100% biochemical progression-free survival rate and no severe toxicities (grade ≥3) reported among 39 patients followed for a median of 57 months.

While HDR treatment is generally safe, factors such as larger prostate size and higher doses to the urethra and bladder can lead to worse short-term urinary quality of life, and older patients may experience more significant sexual function impairment both shortly after treatment and in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient- and treatment-specific predictors of genitourinary function after high-dose-rate monotherapy for favorable prostate cancer. Raleigh, DR., Chang, AJ., Tomlin, B., et al.[2022]

Both single fraction 19Gy and two fractions of 13.5Gy HDR brachytherapy are safe and well tolerated for treating low and intermediate risk prostate cancer, with a median follow-up of 20 months showing manageable toxicity levels.

The two-fraction regimen resulted in higher rates of grade 2 erectile dysfunction and urinary symptoms compared to the single fraction, indicating that while both treatments are effective, the single fraction may have a better quality of life outcome in the first year post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Early toxicity and quality-of life results from a randomized phase II clinical trial of one fraction of 19Gy or two fractions of 13.5Gy. Morton, G., Chung, HT., McGuffin, M., et al.[2022]

High-dose-rate brachytherapy (HDR) combined with external beam radiotherapy shows high efficacy in treating prostate cancer, with relapse-free survival rates exceeding 90% for intermediate-risk patients and over 80% for high-risk patients, outperforming external beam radiotherapy alone.

A specific regimen of a single 15 Gy HDR boost along with 37.5 Gy of hypofractionated radiotherapy is well tolerated and can be completed in under 90 minutes, making it a quick and efficient treatment option for men with high and intermediate risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer: rationale and technique. Morton, GC.[2022]

High dose rate brachytherapy is an effective treatment for localized prostate cancer, allowing for higher radiation doses per session compared to traditional external beam radiation.

This method takes advantage of the unique characteristics of prostate cancer cells, specifically their low alpha/beta ratio, to deliver a biologically effective dose that significantly exceeds what is possible with conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy for prostate cancer: Standard of care and future direction. Thiruthaneeswaran, N., Hoskin, PJ.[2022]

In a study of 623 prostate cancer patients treated with high-dose-rate brachytherapy (HDR-BT) and external beam radiotherapy (EBRT), the 10-year prostate cancer-specific survival rates were excellent, reaching 100% for low-risk patients and 75% for very high-risk patients, indicating effective long-term tumor control.

While the treatment showed manageable levels of toxicity, with 28% experiencing grade 2 genitourinary (GU) toxicities and 12% experiencing gastrointestinal (GI) toxicities, the incidence of severe GU complications was notably higher in patients treated before 2003, highlighting the importance of dose constraints to minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two decades of high dose rate brachytherapy with external beam radiotherapy for prostate cancer. Åström, L., Grusell, E., Sandin, F., et al.[2018]

In a study of 148 prostate cancer patients treated with high-dose-rate (HDR) brachytherapy followed by intensity-modulated radiation therapy (IMRT), the treatment showed a high 4-year biochemical disease-free survival (bDFS) rate of 96.8% using the Phoenix criteria.

The treatment was well tolerated, with low rates of genitourinary (10%) and gastrointestinal (5%) toxicities, indicating that this combination therapy is both effective and safe for patients in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. Chen, WC., Tokita, KM., Ravera, J., et al.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. [2021]

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

ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. [2022]

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

American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes of high-dose-rate brachytherapy for intermediate- and high-risk prostate cancer with a median follow-up of 10 years. [2018]

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

Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. [2019]

6. 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]

7. Ireland pubmed.ncbi.nlm.nih.gov

Single-dose high-dose-rate brachytherapy compared to two and three fractions for locally advanced prostate cancer. [2022]

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

Patient- and treatment-specific predictors of genitourinary function after high-dose-rate monotherapy for favorable prostate cancer. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Early toxicity and quality-of life results from a randomized phase II clinical trial of one fraction of 19Gy or two fractions of 13.5Gy. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer: rationale and technique. [2022]

11. France pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy for prostate cancer: Standard of care and future direction. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

Two decades of high dose rate brachytherapy with external beam radiotherapy for prostate cancer. [2018]

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

Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. [2018]