Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BEACON: HDR Brachytherapy, EBRT and STAD for the Treatment of Local and Pelvic Recurrence of Prostate Cancer After Radiation Therapy (BEACON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553602
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Abhishek A. Solanki, Loyola University Chicago

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
Toxicity rate [ Time Frame: 24 months ]
The primary outcome in this study is the number of acute grade ≥3 radiation-related genitourinary and gastrointestinal toxicities as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BEACON: HDR Brachytherapy, EBRT and STAD for the Treatment of Local and Pelvic Recurrence of Prostate Cancer After Radiation Therapy
Official Title  ICMJE BEACON - A Phase I/II Study of High-dose-rate Brachytherapy and External Beam and Short-term Androgen Deprivation COmbined for the Treatment of Men With Fluciclovine PET Pelvic Nodal Uptake in Locally Recurrent Prostate Cancer After Prior Definitive Radiotherapy
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This 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. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
Detailed Description

Salvage regional and local radiation is frequently utilized across multiple disease sites in oncology for patients who have failed initial radiotherapy. However, in prostate cancer, due to the concern that nodal involvement is a manifestation of widespread distant disease, this type of approach has not typically been pursued. However, with newer imaging modalities such as fluciclovine PET, PSMA pet, and C11 PET, physicians are identifying nodal disease and excluding distant disease better than they ever have before. Thus, in the modern era regional control may translate to improved long-term biochemical control, and prevent the morbidity and mortality associated with clinical progression of recurrent prostate cancer

Thus, in patients who recur both in the prostate and in the pelvic lymph nodes, treating both with radiation could result in meaningful clinical efficacy for patients—similar to other disease sites. However, there are limited data exploring the feasibility and safety of this combination. Therefore, the investigators are conducting this trial, which combines salvage HDR brachytherapy to the local recurrence of the prostate cancer with EBRT to the pelvic lymph nodes, and short-term hormonal therapy, in this group of patients. The investigators hypothesize that this approach can safely be performed without excess toxicity.

Once a patient is deemed eligible for the study and has signed the informed consent form, the patient will start hormone therapy with a LHRH Agonist medication which is an intramuscular injection which patients will receive every 3-6 months for 6 months. Within 10 days of the LHRH injection the patient must start an anti-androgen pill and will take the pill once a day until the last day of radiation. Radiation Therapy will start approximate 2 months after the start of the hormone therapy. Patients will undergo 2 implants with 1 fraction of 12 Gy delivered with each implant, scheduled 1-2 weeks apart when possible, although longer or shorter intervals are acceptable with PI approval. The implant procedure will be done under general anesthesia. Patients will also receive the external beam radiotherapy (for 5 weeks), starting before or after the brachytherapy treatment. Patients will also be asked to complete 2 short quality of life questionnaires before they receive treatment and at follow up visits. Patient will follow up with the radiation oncologist for an exam at 1 month, 3 months, 6 months and 12 months after treatment and then every 6 months for 4 more years then annually thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer - Recurrent
Intervention  ICMJE Radiation: HDR Brachytherapy + EBRT + STAD

HDR Brachytherapy implant: 2 fractions of 12 Gy to the 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 anti-androgen[until end of radiotherapy])

Study Arms  ICMJE Experimental: HDR Brachytherapy + EBRT + STAD

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])

Intervention: Radiation: HDR Brachytherapy + EBRT + STAD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • 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 these specific criteria:

    • Stages cT1-T3a
    • Nx or N0
    • Mx or M0
  • Eligible initial definitive radiotherapy modalities include:

    • External beam radiotherapy, with photon or proton beam therapy
    • Definitive Brachytherapy
    • Stereotactic Body Radiotherapy
  • Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
  • Candidate for hormonal therapy.
  • Current ECOG Performance status Scale 0-2 (Appendix D)
  • Current International Prostate Symptom Score (IPSS) < 20 (Appendix B)
  • Age >18
  • The patient must be medically suitable to receive general or spinal anesthesia.
  • AST, ALT, and alkaline phosphatase < 2 x upper institutional limit within 3 months of registration.
  • The patient must be able and willing to sign a study-specific written informed consent form before study entry.

Exclusion Criteria

  • Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
  • Treatment to a "whole pelvis" field with initial radiotherapy
  • Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes).
  • Patients receiving any other investigational agents.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
  • Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abhishek Solanki, MD 708-216-2556 abhishek.solanki@.lumc.edu
Contact: Beth Chiappetta, RN 708-216-2568 bchiappetta@lumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553602
Other Study ID Numbers  ICMJE 210546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abhishek A. Solanki, Loyola University Chicago
Study Sponsor  ICMJE Loyola University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abhishek Solanki, MD Loyola University Chicago
PRS Account Loyola University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP