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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment for prostate cancer. Researchers aim to determine if administering high-dose radiation therapy (known as High Dose Rate Monotherapy or HDR Brachytherapy) in two doses, three hours apart, is safe and effective. This approach could streamline treatment, reducing time and resource requirements. Men with prostate cancer who have not received prior treatment and are considered low to intermediate risk may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could simplify future prostate cancer treatments.

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 prior data suggests that this HDR brachytherapy technique is safe?

Research has shown that high-dose-rate (HDR) brachytherapy, when used alone, is generally safe for treating prostate cancer. Studies have found it effective for patients with intermediate-risk prostate cancer, with most patients experiencing no major problems.

Traditionally, HDR brachytherapy has been administered over several days or with longer breaks between doses. This new trial tests a shorter break of just 3 hours between treatments. Although this timing is new, HDR brachytherapy itself has a history of safety and effectiveness. Previous patients experienced good results with few serious side effects.

Overall, HDR monotherapy is well-tolerated, meaning most men do not face severe issues after treatment. It is important to note that this trial explores a new treatment schedule, not the use of HDR itself, which has been safely used in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High Dose Rate (HDR) Monotherapy for prostate cancer because it offers a unique approach compared to standard treatments like external beam radiation therapy or low-dose brachytherapy. HDR brachytherapy delivers high doses of radiation directly to the cancer cells in a shorter period, potentially reducing treatment time and side effects. This method administers the therapy in intervals just hours apart, rather than over several days, which could lead to more efficient cancer control and improved patient convenience.

What is the effectiveness track record for HDR brachytherapy in treating prostate cancer?

Research has shown that high dose rate (HDR) brachytherapy, when used alone, effectively treats prostate cancer. One study demonstrated that using HDR in two doses of 13.5 Gy provided strong cancer control over 8 years and was well-tolerated by patients. Another study examined different dosing schedules and confirmed HDR's effectiveness in managing prostate cancer. These findings suggest that HDR brachytherapy can effectively control cancer and is safe for patients. This trial will test a new HDR brachytherapy schedule, with strong evidence supporting HDR monotherapy for prostate cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

I-Chow Hsu, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4003433/

High-dose-rate brachytherapy as monotherapy for prostate ... High-dose-rate (HDR) brachytherapy as monotherapy is a comparatively new brachytherapy procedure for prostate cancer. Although clinical results are not yet ...

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38879130/

Prostate high dose-rate brachytherapy as monotherapy for ... HDR monotherapy delivered in two fractions of 13.5 Gy demonstrated a persistent cancer control rate at 8 years and was well-tolerated.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001484

High-dose-rate brachytherapy boost for prostate cancer: A ... Overall, this study demonstrated the efficacy of EBRT-boosted brachytherapy in the treatment of intermediate- and high-risk prostate cancer, ...

5. tau.amegroups.org tau.amegroups.org/article/view/17950/html

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03424694

HDR Brachytherapy as Monotherapy for Low and ... The purpose of this study is to evaluate High-dose rate (HDR) brachytherapy (1 vs 2 fractions on single implant) as monotherapy for the treatment of low risk ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814025046286

A randomized Phase II trial of High Dose-Rate (HDR) and ... Brachytherapy as monotherapy is a safe and effective treatment for many men with early localized prostate cancer. Current National Comprehensive ...

8. cancercenter.arizona.edu cancercenter.arizona.edu/biblio/high-dose-rate-brachytherapy-monotherapy-without-androgen-deprivation-therapy-intermediate

High-dose-rate brachytherapy monotherapy without androgen ... RESULTS: With a median follow-up of 6.2 years, KM BPFS at 5/8 years was 97%/90%, cause-specific survival at 8 years was 100%, and overall survival at 5/8 years ...