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

NCT ID: NCT03458234

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2023-06-22

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.

Detailed Description

This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focal SBRT with intra-urethral radiotransponder

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.

Group Type: EXPERIMENTAL

16 French Foley Catheter

Intervention Type: 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.

Interventions

16 French Foley Catheter

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• >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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Andrew McDonald

Assistant Professor - Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew M McDonald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

000521070

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300002183

Identifier Type: -

Identifier Source: org_study_id