HDR Monotherapy for Prostate Cancer

Overseen By Jamese Johnson

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Investigational agents

Disqualifiers: Prior prostate treatment, Anesthesia contraindications, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on investigational agents, you cannot participate in the trial.

What data supports the effectiveness of the treatment High Dose Rate Monotherapy for prostate cancer?

Research shows that High Dose Rate (HDR) brachytherapy, used alone, is an effective treatment for localized prostate cancer, with studies reporting positive outcomes in terms of safety and survival without cancer recurrence. This treatment is endorsed by the National Comprehensive Cancer Network (NCCN) as a standard option for patients with localized prostate cancer. ^{1 2 3 4 5}

Is HDR monotherapy for prostate cancer generally safe for humans?

Research shows that HDR monotherapy for prostate cancer is generally safe, with most patients experiencing mild side effects. Serious side effects are rare, and the treatment is considered feasible with minimal adverse events. ^{4 5 6 7 8}

How is HDR Brachytherapy different from other prostate cancer treatments?

HDR Brachytherapy for prostate cancer is unique because it involves delivering a high dose of radiation directly to the prostate in a very precise manner, often in just one or two sessions, minimizing exposure to surrounding tissues. This approach is different from traditional radiation therapy, which typically involves multiple sessions over several weeks. ^{1 2 3 4 9}

Research Team

I-Chow Hsu, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Men aged 18+ with low to intermediate risk prostate cancer, who haven't had treatment for it or androgen deprivation therapy. They must be fit enough for the procedure (ECOG <2), able to consent, and if HIV/HBV/HCV positive, they need controlled viral loads. Those with other cancers can join if it doesn't affect this trial's safety or results.

Inclusion Criteria

I am mostly self-sufficient and can carry out daily activities.

My hepatitis B virus load is undetectable with treatment.

My prostate cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

I had prostate surgery within the last 6 months.

I have received treatment for prostate cancer before.

My pre-treatment assessment indicates I might not be suitable for a specific radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with PSA checks every 3 months for the first year, then every 4 months after year 2, and every 6 months after year 3 until 5 years of follow-up are completed

5 years

Treatment Details

Interventions

• High Dose Rate Monotherapy

Trial Overview The study is testing a high dose rate (HDR) brachytherapy as the only treatment for prostate cancer given in two sessions just 3 hours apart. This approach could make treatment quicker and easier on healthcare systems compared to current methods where treatments are spaced further apart.

Participant Groups

Group I: HDR brachytherapy Experimental Treatment 1 Intervention

Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.

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

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Approved in United States as HDR Brachytherapy for:

• Localized prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

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]

Single-fraction high-dose-rate (HDR) brachytherapy is a safe and effective treatment for early-stage prostate cancer, showing a low cumulative incidence of biochemical recurrence (BCR) at 2 years, particularly in low-risk patients (0% BCR).

In a study of 124 men with a median follow-up of 2.2 years, the overall BCR rate was 9.7%, with no prostate cancer-specific mortality and no severe genitourinary toxicity reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction brachytherapy as monotherapy for early-stage prostate cancer: The UCSF experience. Xu, MJ., Chen, KS., Chang, AJ., 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]

Fractionated high-dose-rate (HDR) brachytherapy as a primary treatment for localized prostate cancer shows a high 5-year biochemical recurrence-free survival (bRFS) rate of 95%, indicating its effectiveness in controlling the disease.

The treatment is associated with low rates of severe toxicity, with only 2% of patients experiencing late grade ≥ 3 genitourinary issues and 0.3% experiencing gastrointestinal toxicity, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate fractionated brachytherapy monotherapy for localized prostate cancer: a systematic review and meta-analysis. Anderson, EM., Kim, S., Sandler, HM., 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]

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]

In a study of 28 patients with low- and intermediate-risk prostate cancer, single fraction high-dose-rate brachytherapy (HDR-BT) delivered 19 Gy showed limited acute toxicity, with only 18% experiencing grade 2 genitourinary side effects and no late grade 3 toxicities reported.

Despite the treatment's low toxicity, the biochemical failure-free survival rates were suboptimal, with 90.7% at two years and 80.6% at three years, indicating that while the treatment is safe, it may not be as effective as hoped for long-term cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction high-dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: toxicities and early outcomes from a single institutional experience. Barnes, JM., Gabani, P., Sanders, M., et al.[2022]

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

Single-fraction brachytherapy as monotherapy for early-stage prostate cancer: The UCSF experience. [2020]

4. 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]

5. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate fractionated brachytherapy monotherapy for localized prostate cancer: a systematic review and meta-analysis. [2022]

6. 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]

7. 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]

8. 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]

9. Poland pubmed.ncbi.nlm.nih.gov

Single fraction high-dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: toxicities and early outcomes from a single institutional experience. [2022]