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

146 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.

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 data supports the effectiveness of the treatment High-Dose Brachytherapy for Prostate Cancer?

Research shows that high-dose brachytherapy, either alone or combined with other treatments, improves outcomes for prostate cancer patients, especially those with challenging cases. It has been found to enhance survival rates and control the disease more effectively than conventional radiation doses. ^{1 2 3 4 5}

Is high-dose brachytherapy safe for humans?

Research shows that high-dose brachytherapy is generally safe for treating prostate cancer, with studies reporting on its safety and short-term outcomes. ^{3 5 6 7 8}

How does high-dose brachytherapy differ from other treatments for prostate cancer?

High-dose brachytherapy for prostate cancer is unique because it involves placing radioactive sources directly into the prostate, allowing for precise delivery of high radiation doses while sparing surrounding healthy tissue. This method is often combined with external-beam radiotherapy for higher-risk cases, offering a radiobiological advantage by exploiting the cancer's sensitivity to radiation fraction size, which is not typically achieved with conventional external beam radiation alone. ^{2 3 9 10 11}

Research Team

Mark Buyyounouski

Principal Investigator

Stanford University Hospitals and Clinics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2004]

2. England pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy as monotherapy for localised prostate cancer: a hypofractionated two-implant approach in 351 consecutive patients. [2023]

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

High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. [2006]

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

Nationwide multi-institutional retrospective analysis of high-dose-rate brachytherapy combined with external beam radiotherapy for localized prostate cancer: An Asian Prostate HDR-BT Consortium. [2018]

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

High dose rate and external beam radiotherapy in locally advanced prostate cancer. [2009]

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

HDR brachytherapy as monotherapy for prostate cancer: A systematic review with meta-analysis. [2021]

7. 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]

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

Prostate high dose rate brachytherapy in a free-standing cancer center setting. [2016]

9. England pubmed.ncbi.nlm.nih.gov

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

10. France pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy for prostate cancer: Standard of care and future direction. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

High-dose-rate intensity modulated brachytherapy with external-beam radiotherapy improves local and biochemical control in patients with high-risk prostate cancer. [2021]