What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as HDR Brachytherapy, EBRT, and STAD, have distinct side effects. HDR Brachytherapy can cause urinary symptoms like urgency, frequency, and incontinence. EBRT is associated with acute effects such as skin erythema and mucositis, and long-term effects including bowel symptoms and sexual dysfunction. STAD, which reduces androgen levels, can lead to hot flashes, decreased libido, fatigue, and cardiovascular issues. Combining these treatments may amplify these side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that align with the methods used in the combination of HDR Brachytherapy, EBRT, and STAD. HDR Brachytherapy, which delivers high doses of radiation directly to cancer cells, is a well-established treatment. External Beam Radiotherapy (EBRT) is also widely used and targets the pelvis and lymph nodes with external radiation. For androgen deprivation therapy (ADT), drugs like leuprolide, goserelin, and degarelix are FDA-approved to reduce androgen levels and inhibit cancer growth. Additionally, radium-223 has been approved for targeting bone metastases in castration-resistant prostate cancer, demonstrating the FDA's support for advanced radiation therapies in prostate cancer treatment.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: 1) PSMA-targeted radioligand therapy, which uses a radioactive substance to target prostate-specific membrane antigen (PSMA) on cancer cells; 2) Immunotherapy approaches such as checkpoint inhibitors (e.g., pembrolizumab) for patients with specific genetic markers; 3) Advanced imaging-guided radiation therapy techniques like stereotactic body radiotherapy (SBRT) for precise targeting of tumors; 4) Combination therapies involving novel androgen receptor inhibitors (e.g., enzalutamide, apalutamide) with existing treatments to enhance efficacy.

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Radiation Therapy

Combined Radiation Therapy for Recurrent Prostate Cancer (BEACON Trial)

Phase 1 & 2

Waitlist Available

Led By Abhishek Solanki, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer

Initial cancer diagnosis that fits specific criteria: Stages cT1-T3a, Nx or N0, Mx or M0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial tests a combination of internal and external radiation along with hormone therapy for men whose prostate cancer has returned after previous treatment. The treatment works by directly attacking cancer cells in the prostate and pelvis and reducing hormones that help cancer grow. Enzalutamide is approved by the FDA for the treatment of prostate cancer.

Who is the study for?

This trial is for men over 18 with prostate cancer that has returned after radiation therapy, without distant metastases or severe previous radiotherapy side effects. They must be fit for anesthesia and agree to hormone therapy. Excluded are those who've had 'whole pelvis' treatment, recent chemo/immunotherapy, serious illnesses, or conditions affecting study compliance.

What is being tested?

The BEACON trial tests a combination of HDR brachytherapy (temporary placement of radioactive material in the prostate), EBRT to the pelvis targeting suspicious lymph nodes on PET scan, and STAD hormonal therapy for treating recurrent prostate cancer post-radiotherapy. The effectiveness and safety will be monitored over time.

What are the potential side effects?

Potential side effects include discomfort from minimally invasive procedures, reactions to radiation like skin changes or fatigue, hormonal therapy effects such as mood swings or hot flashes, and possible organ-specific inflammation due to targeted pelvic radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer came back in the same area after radiation.

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My initial cancer diagnosis was at an early to mid-stage, without confirmed spread to distant organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: HDR Brachytherapy + EBRT + STADExperimental Treatment1 Intervention

Day 1: HDR Brachytherapy implant: 2 fractions of 12 Gy to prostate/ proximal SV. EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET positive lesions. 6 months hormonal therapy(LHRH agonist and antiandrogen \[until the end of radiotherapy\])

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

HDR brachytherapy delivers high doses of radiation directly to prostate cancer cells, minimizing damage to surrounding tissues. EBRT targets the pelvis and lymph nodes with external radiation to destroy cancer cells in these regions. STAD reduces androgen levels, which prostate cancer cells need to grow, thereby inhibiting their proliferation. These mechanisms are important for prostate cancer patients as they offer a multi-faceted approach to treatment, potentially increasing effectiveness and reducing side effects.

The impact of brachytherapy on prostate cancer-specific mortality for definitive radiation therapy of high-grade prostate cancer: a population-based analysis.[Brachytherapy in men with prostate cancer: update on indications and outcomes].