High-Dose Brachytherapy for Prostate Cancer

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Clinical T4, PSA >= 150, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4-36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of high-dose brachytherapy for treating prostate cancer that hasn't spread. Brachytherapy involves placing radioactive material directly into or near the tumor, which may benefit some prostate cancer patients. The trial also monitors any side effects from this treatment. Men with doctor-confirmed prostate cancer, showing no signs of spreading to lymph nodes or bones, might be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future prostate cancer treatments.

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 prior data suggests that high-dose brachytherapy is safe for treating prostate cancer?

Research has shown that high-dose brachytherapy is generally safe for treating prostate cancer. This treatment involves placing radioactive materials directly in or near the tumor and is well-tolerated by patients.

Administering two doses of high-dose-rate brachytherapy appears safe. Patients with intermediate-risk prostate cancer have found it both safe and effective as a standalone treatment. Even those with other health conditions, such as inflammatory bowel disease, experience few serious side effects.

Overall, high-dose brachytherapy offers a promising and safe option for those with prostate cancer that hasn't spread. ^{1 2 3 4 5}

Why are researchers excited about this trial?

High-dose brachytherapy is unique because it delivers a concentrated dose of radiation directly to the prostate, minimizing damage to surrounding healthy tissues. Unlike traditional external beam radiation therapy, which takes several weeks, this method can be completed in just two sessions, potentially reducing treatment time and side effects. Researchers are excited about this because it could offer a more efficient and targeted approach for treating prostate cancer, especially when combined with hormone therapies like ADT and LHRH agonists, potentially improving outcomes for patients with both intermediate and high-risk prostate cancer.

What evidence suggests that high-dose brachytherapy might be an effective treatment for prostate cancer?

Research has shown that high-dose brachytherapy, a type of radiation treatment placed directly into or near a tumor, can be effective for prostate cancer. In this trial, participants will undergo high-dose-rate brachytherapy over two fractions. Studies have found that this method, especially when combined with external beam radiation therapy, helps patients live longer and reduces the chance of cancer spreading. High-dose brachytherapy alone has also shown promise in reducing cancer recurrence. Evidence indicates that it causes fewer side effects compared to other radiation treatments. Additionally, this treatment is more convenient for patients because it requires fewer visits. ^{1 3 6 7 8}

Who Is on the Research Team?

Mark Buyyounouski

Principal Investigator

Stanford University Hospitals and Clinics

Are You a Good Fit for This Trial?

Men with prostate cancer that hasn't spread, having a PSA level below 150 ng/mL and no bone metastases. They should have an AUA Symptom Index score of 20 or less, Gleason score between 6-10, and clinically negative lymph nodes. Men who've had rectal surgery/fistula, T4 disease, high PSA levels (>=150 ng/mL), prior radical treatments for prostate cancer within three years or severe health issues like recent heart problems are excluded.

Inclusion Criteria

American Urological Association Symptom Index (AUA SI) =< 20

My prostate cancer has a Gleason score between 6 and 10.

My cancer has not spread to my bones, confirmed by a scan.

Exclusion Criteria

AUA SI > 20

I have had a rectal fistula.

I have had surgery on my rectum.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo high-dose-rate brachytherapy over 2 fractions and may receive ADT and LHRH agonist therapy

4-36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3, 6, 9, and 12 months, then yearly

What Are the Treatments Tested in This Trial?

Interventions

• High-Dose Brachytherapy

Trial Overview The trial is testing high-dose brachytherapy—a type of radiation where radioactive material is placed near the tumor—to see how well it works and what side effects it has in treating localized prostate cancer compared to other treatments.

How Is the Trial Designed?

Group I: Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) Experimental Treatment 8 Interventions

Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Brachytherapy, particularly high-dose-rate (HDR) brachytherapy, effectively delivers targeted radiation to prostate cancer, showing disease-free survival rates of 68-93% and local control rates over 90% in patients with higher-risk localized disease.

HDR brachytherapy is well tolerated, with the most common side effect being urethral stricture occurring in about 8% of patients, and early results suggest it may also be beneficial for low-risk disease when used alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging role of high-dose-rate brachytherapy for prostate cancer. Morton, GC.[2019]

In a study of 207 prostate cancer patients with poor prognostic factors, a high dose rate brachytherapy boost combined with pelvic radiotherapy resulted in a 5-year biochemical control rate of 74%, with even higher rates for patients with fewer poor prognostic factors.

The treatment demonstrated a high overall survival rate of 92% and low complication rates (8% for severe genitourinary issues), indicating that this approach is both effective and safe for managing advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformal high dose rate brachytherapy improves biochemical control and cause specific survival in patients with prostate cancer and poor prognostic factors. Martinez, A., Gonzalez, J., Spencer, W., et al.[2004]

In a study of 131 prostate cancer patients treated with high dose rate brachytherapy and external beam radiation, the 5-year biochemical control rate was 81%, indicating effective cancer management over a median follow-up of 62.8 months.

The treatment was associated with minimal severe complications, with only 1.5% experiencing grade 3 acute urinary toxicity and 4% having grade 3 late genitourinary toxicity, demonstrating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate and external beam radiotherapy in locally advanced prostate cancer. Viani, GA., Pellizzon, AC., Guimarães, FS., et al.[2009]

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 309 prostate cancer patients treated with high dose rate brachytherapy and external beam radiation, the 5-year biochemical control rate was 86%, indicating effective cancer management over the follow-up period of 59 months.

The treatment was associated with minimal severe complications, with only 2 cases of grade 3 acute urinary toxicity and 4% experiencing grade 3 genitourinary toxicity, demonstrating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. Phan, TP., Syed, AM., Puthawala, A., et al.[2006]

Prostate high dose rate (HDR) brachytherapy can be safely performed in a free-standing cancer center, with only 3.7% of procedures resulting in complications requiring catheter placement.

The treatment is well tolerated, with 20% of patients experiencing significant post-implant dysuria lasting an average of 7.5 days, indicating manageable side effects when combined with external beam radiation and hormonal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose rate brachytherapy in a free-standing cancer center setting. Tharp, M., Bennett, R., Burns, J., et al.[2016]

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

High-dose-rate brachytherapy boost for prostate cancer: A ... Our study provides essential data on the clinical results of prostate brachytherapy in combination with EBRT. The rates of OS, MFS and BPFS ...

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. 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 ... A randomized trial comparing low- and high-dose rate brachytherapy, combined with external beam radiotherapy, for intermediate- or high-risk prostate cancer.

5. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2025.1598726/full

High-dose-rate brachytherapy lowers travel burden for men ... HDR-BT monotherapy significantly reduces the travel burden compared with EBRT for localized prostate cancer, with minimal treatment-associated toxicity.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000138

Effectiveness, toxicity and impact on quality of life of high ... High-dose-rate brachytherapy is an option for prostate cancer patients. •. Two fractions of high-dose-rate brachytherapy as monotherpy appear to be safe. •.

7. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer a single high-dose-rate (HDR) of 15 Gy combined with external radiation therapy of 40 to 50 Gy results in disease-free survival of over 90% for intermediate- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38584887/

Safety of high-dose-rate brachytherapy in patients with ... HDR brachytherapy appears to be a safe and tolerable treatment modality for patients with prostate cancer and IBD, with minimal acute and ...