RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy

NCT03458234 | Terminated Results FDA Device

• 2 other identifiers: IRB-300002183000521070
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.

Conditions

Prostate Cancer

Keywords

Focal therapy; Prostate cancer; SBRT; Intra-urethral transponder

Outcome Measures

Primary Outcomes (1)

• Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.

  Confirm the technical feasibility of using focal prostate stereotactic body radiotherapy (SBRT) instead of traditional treatment methods using a 16-french Foley catheter and real time guidance by intra-urethral radiotransponder beacons.Feasibility will be defined as the ability of the treatment to take place as planned.

  2 years

Secondary Outcomes (3)

• Assess Early Efficacy

  Within 6 months of completion of radiation therapy

• Assess Late Toxicity

  Within 6 months of completion of radiation therapy

• Assess Quality of Life

  Within 6 months of completion of radiation therapy

Study Arms (1)

Focal SBRT with intra-urethral radiotransponder

EXPERIMENTAL

This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.

Device: 16 French Foley Catheter

Interventions

16 French Foley Catheter DEVICE

A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra. Featuring two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag. Foley catheters are usually constructed out of either silicone or latex.

Focal SBRT with intra-urethral radiotransponder

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration
• Gleason score 3+3 or 3+4
• PSA \<10 ng/mL within 3 months of enrollment
• Clinical stage T1a-T2a by digital rectal exam
• Up to 2 intraprostatic nodules visible on MRI, with combined volume \<50% of the total prostate volume
• Karnofsky Performance Status (KPS) \>70%.
• Life expectancy \>10 years
• Age ≥ 19 years
• Subjects given written informed consent

You may not qualify if:

• \>2 MRI defined nodules representing prostate cancer
• Total volume of MRI nodules exceeding 50% of total prostate volume
• Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)
• American Urological Association (AUA) urinary score ≥ 18.
• History of inflammatory bowel disease.
• Prior pelvic surgery
• Prior treatment for prostate cancer
• Platelet count \< 70,000/µL
• Contraindication to MRI such as implanted devices.
• Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.

Results Point of Contact

• Title: Andrew McDonald, MD; Principal Investigator
• Organization: University of Alabama at Birmingham (UAB)

ammcdonald@uabmc.edu

(205) 934-5670

Study Officials

• Andrew M McDonald, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Radiation Oncology

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: January 28, 2020
• Primary Completion: April 20, 2023
• Study Completion: June 22, 2023
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-05

Locations

US (1)