HDR Brachytherapy for Prostate Cancer

Recruiting at 1 trial location

Overseen By Debbie Nathan, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational chemotherapy, Anti-coagulation therapy

Disqualifiers: Cognitive impairment, Pregnancy, Autoimmune disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Varies per individual needs

43 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving chemotherapy within 5 days before brachytherapy, except for certain gynecological cancer patients. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment HDR Brachytherapy for prostate cancer?

Research shows that high-dose-rate (HDR) brachytherapy is a promising treatment for prostate cancer, with studies indicating it can improve survival rates when used alongside other radiation therapies. It is considered potentially curative and is supported by a growing body of literature as an effective treatment for localized prostate cancer. ^{1 2 3 4 5}

Is HDR Brachytherapy generally safe for humans?

Research shows that HDR Brachytherapy is generally safe for treating prostate cancer, with most patients experiencing only mild side effects. Serious side effects are rare, and the treatment is considered feasible with minimal adverse events. ^{6 7 8 9 10}

How is HDR Brachytherapy different from other treatments for prostate cancer?

HDR Brachytherapy is unique because it involves placing a temporary radiation source directly inside the prostate, allowing for a high dose of radiation to be delivered precisely to the cancer cells while minimizing exposure to surrounding healthy tissue. This method can be used alone or in combination with external beam radiotherapy, offering a targeted approach that can potentially improve outcomes compared to traditional radiation therapies. ^{1 11 12 13 14}

What is the purpose of this trial?

Background: * One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. * Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: * To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch. Eligibility: * Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: * In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. * Each treatment will take place in the Radiation Oncology Clinic. * If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. * The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. * The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. * Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.

Research Team

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults over 18 with various cancers (like endometrial, cervical, esophageal, biliary, prostate) who may benefit from high-dose brachytherapy. Participants must be in relatively good health and have a primary oncologist to collaborate on their care. They should agree to use birth control if they can have children.

Inclusion Criteria

I have cervical cancer.

I have lung cancer.

My cancer has returned at the top part of my vagina.

Exclusion Criteria

Pregnant or breast-feeding females

I am able to follow the treatment plan as directed.

I have abnormal bleeding times or am on blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose rate brachytherapy as part of their cancer treatment

Varies per individual needs

Multiple visits for brachytherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 1, 3, 6, 9, and 12 months

Treatment Details

Interventions

• HDR Brachytherapy

Trial Overview The study tests high-dose rate brachytherapy—a type of internal radiation therapy—on patients with specific cancers. It involves placing devices inside or near the tumor area and delivering concentrated radiation directly to the cancer cells.

Participant Groups

Group I: 1/Radiation Therapy Experimental Treatment 4 Interventions

Radiation therapy given as high dose radiation (HDR) Brachytherapy.

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

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

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]

In a randomized phase II trial involving 170 patients with localized prostate cancer, HDR brachytherapy delivered in two fractions of 13.5 Gy resulted in significantly better 5-year biochemical disease-free survival (95%) compared to a single fraction of 19 Gy (73.5%).

The two-fraction treatment was well tolerated, with low rates of late rectal toxicity (1%) and manageable urinary toxicity (45% grade 2), indicating it is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Morton, G., McGuffin, M., Chung, HT., et al.[2021]

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]

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]

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]

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 as a monotherapy in two fractions within one day is feasible for treating localized prostate cancer, including high-/very high-risk cases, with a median follow-up of 30.1 months showing minimal adverse events (AEs).

The treatment resulted in a high biochemical failure-free survival rate of 91.6% overall and 88.0% for high-/very high-risk patients, indicating effective disease control with acceptable safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early outcome of high-dose-rate Ir-192 brachytherapy as monotherapy in two fractions within 1 day for high-/very high-risk prostate cancer. Ashida, S., Yamasaki, I., Tamura, K., et al.[2020]

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 (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]

High-dose-rate (HDR) brachytherapy is a safe and effective treatment for low-risk prostate cancer, with 45% of patients experiencing some form of acute toxicity, primarily grade 1 urinary toxicity, within three months post-treatment.

The study found that urinary toxicity was significantly linked to the dose received by the urethra, with patients receiving over 111.3% of the prescribed dose being four times more likely to experience urinary issues, highlighting the importance of careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. Cendales, R., Alwers, E., Cifuentes, J., et al.[2020]

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]

High Dose Rate Brachytherapy (HDR-BT) is effective for treating prostate cancer, initially used as a boost to external beam therapy but now also as a standalone treatment (HDR monotherapy).

The review highlights clinical outcomes and toxicity results from key studies, supporting the use of HDR-BT based on its favorable physical and radiobiological characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. De Bari, B., Daidone, A., Alongi, F.[2018]

High-dose rate brachytherapy (HDR-BT) shows high efficacy as a monotherapy for localized prostate cancer, with local control rates between 97-100% and biochemical progression-free survival rates of 85-100% for low-risk patients and 79-92% for high-risk patients based on a systematic review of 14 studies.

While HDR-BT is generally safe, most studies reported acute and long-term genitourinary complications, which were more common and severe than gastrointestinal issues, indicating a need for further research on long-term safety and efficacy, especially in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy. Sánchez-Gómez, LM., Polo-deSantos, M., Rodríguez-Melcón, JI., et al.[2022]

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. Ireland pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. [2021]

3. 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]

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

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

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

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

6. Ireland pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Feasibility and early outcome of high-dose-rate Ir-192 brachytherapy as monotherapy in two fractions within 1 day for high-/very high-risk prostate cancer. [2020]

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. 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]

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

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. [2020]

11. Ireland pubmed.ncbi.nlm.nih.gov

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

12. Netherlands pubmed.ncbi.nlm.nih.gov

Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. [2018]

13. Spain pubmed.ncbi.nlm.nih.gov

High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy. [2022]

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

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