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Radiation Therapy

Combined Radiation Therapy for Recurrent Prostate Cancer (BEACON Trial)

Phase 1 & 2

Recruiting

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

BEACON Trial Summary

This trial is testing a treatment for prostate cancer that has come back after prior radiotherapy, which involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan.

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.Check my eligibility

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.See study design

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.

BEACON Trial 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.

BEACON Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Toxicity rate

BEACON 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

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,910 Total Patients Enrolled

Abhishek Solanki, MDPrincipal InvestigatorLoyola University Chicago

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

EBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03553602 — Phase 1 & 2

Prostate Cancer Research Study Groups: HDR Brachytherapy + EBRT + STAD

Prostate Cancer Clinical Trial 2023: EBRT Highlights & Side Effects. Trial Name: NCT03553602 — Phase 1 & 2

EBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03553602 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to participate in this research endeavor?

"According to the clinicaltrials.gov website, this research endeavour is currently recruiting participants and was initially made public on May 29th 2018 with a recent update transpired in 2020 of that same month."

Answered by AI

Is the age criteria for this medical trial limited to those over 85 years old?

"This trial is open to participants between 18 and 99 years old. For those under the age of 18, there are 231 different clinical trials available, while 2110 exams can be found for individuals over 65."

Answered by AI

How many subjects are being monitored for the current clinical investigation?

"Affirmative. The clinical trial registry on clinicaltrials.gov confirms that this experiment, which was first listed in May 2018, is actively recruiting participants. 24 people need to be recruited from one medical centre for the completion of this research project."

Answered by AI

Who is the ideal candidate for participation in this research project?

"This clinical trial is seeking 24 individuals with recurrent prostate cancer aged between 18 and 99. Eligibility criteria include: biopsy-proven adenocarcinoma of the prostate, Mx or M0 stages cT1 to T3a, Nx or N0 status, external beam radiotherapy using photons/protons, definitive brachytherapy, stereotactic body radiotherapy (SBRT), F18-fluciclovine positive pelvic nodes without distal metastasis nor lymph node involvement beyond this area; also a candidate for hormonal therapy plus an ECOG performance score ranging from 0 to 2 on the"

Answered by AI

Recent research and studies

Journal of UrologyJournal

Anatomical Patterns of Recurrence Following Biochemical Relapse in the Dose Escalation Era of External Beam Radiotherapy for Prostate Cancer

Zumsteg, Zachary S., Daniel E. Spratt, Paul B. Romesser, Xin Pei, Zhigang Zhang, Marisa Kollmeier, Sean McBride, Yoshiya Yamada, and Michael J. Zelefsky. 2015. “Anatomical Patterns of Recurrence Following Biochemical Relapse in the Dose Escalation Era of External Beam Radiotherapy for Prostate Cancer”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2015.06.100.

European UrologyJournal

Long-term Outcomes of Salvage Lymph Node Dissection for Clinically Recurrent Prostate Cancer: Results of a Single-institution Series with a Minimum Follow-up of 5 Years

Suardi, Nazareno, Giorgio Gandaglia, Andrea Gallina, Ettore Di Trapani, Vincenzo Scattoni, Damiano Vizziello, Vito Cucchiara, et al.. 2015. “Long-term Outcomes of Salvage Lymph Node Dissection for Clinically Recurrent Prostate Cancer: Results of a Single-institution Series with a Minimum Follow-up of 5 Years”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2014.02.011.

International Journal of Radiation Oncology*Biology*PhysicsJournal

Salvage HDR Brachytherapy for Recurrent Prostate Cancer After Previous Definitive Radiation Therapy: 5-year Outcomes

Chen, Chien Peter, Vivian Weinberg, Katsuto Shinohara, Mack Roach III, Marc Nash, Alexander Gottschalk, Albert J. Chang, and I-Chow Hsu. 2013. “Salvage HDR Brachytherapy for Recurrent Prostate Cancer After Previous Definitive Radiation Therapy: 5-year Outcomes”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2013.01.027.

Journal of Clinical EpidemiologyJournal