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

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ClinicalTrials.gov Identifier: NCT03458234
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew McDonald, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: 16 French Foley Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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.
Device: 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.





Primary Outcome Measures :
  1. Confirm the feasibility of focal prostate stereotactic body radiotherapy (SBRT) with real time guidance by intra-urethral radiotransponder beacons. [ Time Frame: 2 years ]
    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 :
  1. Assess early efficacy [ Time Frame: Within 6 months of completion of radiation therapy ]
    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

  2. Assess late toxicity [ Time Frame: Within 6 months of completion of radiation therapy ]
    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.

  3. Assess quality of life [ Time Frame: Within 6 months of completion of radiation therapy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458234


Contacts
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Contact: Valerie P Powell 205-975-9316 vpowell@uabmc.edu
Contact: Andrew M McDonald, MD ammcdonald@uabmc.edu

Locations
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United States, Alabama
Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Andrew M McDonald, MD University of Alabama at Birmingham
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Responsible Party: Andrew McDonald, Assistant Professor - Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03458234    
Other Study ID Numbers: IRB-300002183
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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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
Keywords provided by Andrew McDonald, University of Alabama at Birmingham:
Focal therapy
Prostate cancer
SBRT
Intra-urethral transponder
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases