Clinical Trials /

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

NCT03458234

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: IRB-300002183
  • NCT ID: NCT03458234

Conditions

  • Prostate Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Focal SBRT with intra-urethral radiotransponderExperimentalThis 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.

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:19 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Confirm the feasibility of focal prostate stereotactic body radiotherapy (SBRT) with real time guidance by intra-urethral radiotransponder beacons.
    Time Frame:2 years
    Safety Issue:
    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.

    Secondary Outcome Measures

    Measure:Assess early efficacy
    Time Frame:Within 6 months of completion of radiation therapy
    Safety Issue:
    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
    Measure:Assess late toxicity
    Time Frame:Within 6 months of completion of radiation therapy
    Safety Issue:
    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.
    Measure:Assess quality of life
    Time Frame:Within 6 months of completion of radiation therapy
    Safety Issue:
    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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Alabama at Birmingham

    Trial Keywords

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

    Last Updated

    November 6, 2019