HDR Brachytherapy for Prostate Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores high-dose radiation brachytherapy (HDR Brachytherapy) to enhance treatment for various cancers by delivering radiation directly inside the body where needed most. It targets patients with specific cancers such as prostate, breast, lung, cervical, and endometrial cancer, who might benefit from this targeted approach. Patients with localized prostate cancer or other cancers unsuitable for surgery might be ideal candidates. The trial aims to assess the effectiveness and safety of this treatment in improving outcomes and managing cancer symptoms. As a Phase 2 trial, the research focuses on evaluating the treatment's efficacy in an initial, smaller group of participants, offering them a chance to contribute to advancements in cancer care.

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 prior data suggests that HDR Brachytherapy is safe for prostate cancer treatment?

Research has shown that high-dose-rate (HDR) brachytherapy for prostate cancer is generally well-tolerated by patients. Past studies demonstrated that HDR brachytherapy effectively controls the disease and works well alongside external beam radiation therapy. This combination targets cancer cells effectively while minimizing exposure to nearby healthy tissues.

These studies reported that HDR brachytherapy has been safely used to treat prostate cancer, yielding positive long-term results. Side effects are usually manageable and similar to those seen with other radiation therapies. Its common use in the United States and Europe for prostate cancer indicates a high level of safety and effectiveness.

While individual experiences may differ, existing research provides a reassuring view of HDR brachytherapy as a safe option for many prostate cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

HDR Brachytherapy is unique because it delivers high doses of radiation directly to the prostate cancer cells, minimizing exposure to surrounding healthy tissues. Unlike standard external beam radiation therapy that can take several weeks, HDR Brachytherapy is typically completed in just a few sessions, offering a more convenient and quicker treatment option. Researchers are excited about this approach because it has the potential to reduce side effects and improve the precision and effectiveness of prostate cancer treatment.

What evidence suggests that HDR Brachytherapy is effective for prostate cancer?

Research has shown that high-dose-rate (HDR) brachytherapy, which participants in this trial will receive, effectively treats prostate cancer. Studies have found that it provides strong control over the disease for men whose cancer has not spread. In one study, 85.7% of patients did not experience cancer progression after treatment. Another study found that HDR brachytherapy works as well as other treatments, such as low-dose-rate brachytherapy, with about 85% of patients experiencing stable or reduced PSA levels, indicators of prostate cancer activity. Overall, HDR brachytherapy has strong evidence supporting its effectiveness in controlling prostate cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

My endometrial cancer cannot be removed by surgery.

I cannot have surgery and need treatment for cervical cancer that cannot be removed.

Exclusion Criteria

Pregnant or breast-feeding females

Nothing in my body prevents safe use of internal radiation therapy.

I am able to follow the treatment plan as directed.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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 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]

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]

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 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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ...

These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...

2.

pmc.ncbi.nlm.nih.gov

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

High dose-rate brachytherapy in the treatment of prostate cancer

In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...

3.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ...

We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2452109425001484

High-dose-rate brachytherapy boost for prostate cancer: A ...

This study reports BPFS of 85.7%, local relapse-free survival of 97%, distant MFS of 97.6% and OS of 77.6%20.

5.

urotoday.com

urotoday.com/conference-highlights/astro-2024/astro-2024-prostate-cancer/155302-astro-2024-a-randomized-comparison-of-low-dose-rate-or-high-dose-rate-brachytherapy-combined-with-external-beam-radiation-for-unfavorable-intermediate-or-high-risk-prostate-cancer-efficacy-results-at-median-6-years.html

ASTRO 2024: A Randomized Comparison of Low Dose ...

HDR and LDR boost both appear to be highly effective for the treatment of unfavorable risk prostate cancer, with 85% biochemical cure (i.e., PSA ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01655836

High-Dose Rate Brachytherapy and Stereotactic Body ...

HDR brachytherapy is a standard of care in the United States and Europe to deliver a radiation boost to the prostate when combined with external beam radiation.