Focal Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Metastatic disease, Prior pelvic radiotherapy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.

Who Is on the Research Team?

Alan C Lee

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

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.

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

How Is the Trial Designed?

Group I: Treatment (HDR-BT) Experimental Treatment 6 Interventions

Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+