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RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy (RAD1801)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
16 French Foley Catheter
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal therapy, Prostate cancer, SBRT, Intra-urethral transponder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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
  • Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.
  • Platelet count < 70,000/µL
  • Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
  • Contraindication to MRI such as implanted devices.
  • Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT

Sites / Locations

  • Hazelrig-Salter Radiation Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal SBRT with intra-urethral radiotransponder

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assess early efficacy
Clinically assess early efficacy for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer.Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer
Assess late toxicity
Clinically assess late toxicity for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late toxicity (defined as toxicity occurring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Assess quality of life
Clinically assess quality of life for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.

Full Information

First Posted
March 1, 2018
Last Updated
March 23, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03458234
Brief Title
RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Acronym
RAD1801
Official Title
Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Focal therapy, Prostate cancer, SBRT, Intra-urethral transponder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focal SBRT with intra-urethral radiotransponder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
16 French Foley Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Confirm the feasibility of focal prostate stereotactic body radiotherapy (SBRT) with real time guidance by intra-urethral radiotransponder beacons.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Assess early efficacy
Description
Clinically assess early efficacy for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer.Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer
Time Frame
Within 6 months of completion of radiation therapy
Title
Assess late toxicity
Description
Clinically assess late toxicity for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late toxicity (defined as toxicity occurring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Time Frame
Within 6 months of completion of radiation therapy
Title
Assess quality of life
Description
Clinically assess quality of life for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.
Time Frame
Within 6 months of completion of radiation therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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 Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria. Platelet count < 70,000/µL Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria. Contraindication to MRI such as implanted devices. Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M McDonald, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazelrig-Salter Radiation Oncology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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