45 Participants NeededMy employer runs this trial

Focal Radiation Therapy for Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating prostate cancer using high-dose rate brachytherapy (HDR-BT), which places radioactive material directly in or near the tumor. The aim is to control the cancer locally while minimizing side effects often associated with traditional treatments like surgery and radiation. Men recently diagnosed with prostate cancer and confirmed tumors from an MRI (a special type of scan) may be suitable candidates for this trial. The treatment plan includes receiving HDR-BT up to two times, along with regular scans and tests. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that might not be available elsewhere.

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 this focal radiation therapy is safe for prostate cancer patients?

A previous study found high-dose rate brachytherapy (HDR-BT) to be a safe and manageable treatment for prostate cancer. This method places radioactive material directly in or near the tumor. Research has shown that HDR-BT effectively controls cancer while maintaining low side effects. One study found that even patients with prior radiation treatment handled HDR-BT well. Another study reported very few severe side effects, even after many years. Overall, HDR-BT has a strong safety record for treating prostate cancer.12345

Why are researchers excited about this trial?

High-Dose Rate Brachytherapy (HDR-BT) is unique because it delivers a concentrated dose of radiation directly to the dominant prostate lesion, reducing exposure to surrounding healthy tissues. Unlike traditional external beam radiation, which can take several weeks, HDR-BT is completed in just one or two sessions, spaced a few weeks apart. Researchers are excited about this treatment because it has the potential to minimize side effects while effectively targeting cancer cells, offering a promising alternative to more invasive prostate cancer treatments.

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

Research has shown that high-dose rate brachytherapy (HDR-BT), the treatment under study in this trial, effectively treats prostate cancer. HDR-BT controls cancer by placing radiation directly inside or near the tumor. One study found that over 90% of patients with intermediate-risk prostate cancer remained disease-free after HDR-BT. Another report highlighted that HDR-BT provides strong disease control for men with localized prostate cancer. Overall, HDR-BT is a promising treatment option that may reduce side effects compared to traditional methods.678910

Who Is on the Research Team?

AC

Alan C Lee

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men age 40 or older with recently diagnosed prostate cancer confirmed by biopsy and MRI, who are in good physical condition. They must not have advanced or metastatic disease, large tumors (over 40% of the prostate), high-risk features outside the target area, or prior pelvic radiation.

Inclusion Criteria

I was diagnosed with prostate adenocarcinoma by biopsy in the last 90 days.
Multiparametric MRI (mp-MRI) confirmed lesion(s)
I am fully active or have only minor limitations in daily activities.
See 2 more

Exclusion Criteria

I have had radiation therapy to my pelvic area.
My cancer has spread to my lymph nodes or other parts of my body.
My prostate tumor covers more than 40% of my prostate.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions.

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 6 weeks, every 3 months for the first 2 years, every 6 months for years 3 and 4, then annually thereafter.

5 years
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • High-Dose Rate Brachytherapy

Trial Overview

The study is testing focal high-dose rate brachytherapy (HDR-BT), a type of internal radiation where radioactive material is placed near the tumor. It aims to control prostate cancer while reducing side effects compared to standard treatments. Imaging and biopsies will help guide treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (HDR-BT)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Citations

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 ...

Effectiveness, toxicity and impact on quality of life of high ...

The aim of this retrospective, single-center cohort study was to evaluate the effectiveness and safety of two-fraction high-dose-rate brachytherapy (HDR-BT) as ...

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- ...

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 ...

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.

pubmed.ncbi.nlm.nih.gov

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

Safety of high-dose-rate brachytherapy in patients with ...

Conclusions: HDR brachytherapy appears to be a safe and tolerable treatment modality for patients with prostate cancer and IBD, with minimal ...

Safety of high-dose rate (HDR) brachytherapy for patients ...

This technique has been shown to be safe and effective for the treatment of prostate cancer in patients who received prior prostate radiation and has a ...

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

Purpose: To evaluate the long-term oncological outcomes and toxicity profile based on 24 years of follow-up in patients with localized very high-risk ...

High-dose-rate (HDR) brachytherapy boost in combination ...

The degree of dose escalation achievable with. HDR brachytherapy, compared to dose-escalated EBRT alone, is therefore potentially radiobiologically more lethal.

High‐dose‐rate brachytherapy for prostate cancer - PMC - NIH

The reported 7‐year biochemical relapse‐free survival and metastasis‐free survival rates were 88% and 93%, respectively. The reported incidence of late grade 3 ...