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NCT03458234 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2024-05-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Assess Early Efficacy

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outcome · POSTED

Assess Late Toxicity

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outcome · POSTED

Assess Quality of Life

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
19 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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 Names
    1. Device: 16 French Foley Catheter
    label
    Focal SBRT with intra-urethral radiotransponder
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Focal SBRT with intra-urethral radiotransponder
    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.
    name
    16 French Foley Catheter
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.
    time Frame
    2 years
secondary Outcomes
  1. 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 Early Efficacy
    time Frame
    Within 6 months of completion of radiation therapy
  2. 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 Late Toxicity
    time Frame
    Within 6 months of completion of radiation therapy
  3. 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.
    measure
    Assess Quality of Life
    time Frame
    Within 6 months of completion of radiation therapy
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-970165e823649d4fec45
      requested nct id
      NCT03458234
      primary nct id
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      source kind
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      source record id
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      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      payload sha256
      09dcf5d0903b47934215dbc5486f9d2707400d6fbcf55f0f6221a8eefe688c6f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-970165e823649d4fec45
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03458234
      occurrences
      1. context exact
        NCT03458234
        end
        11
        exact text
        NCT03458234
        start
        0
      offset unit
      unicode_code_points
      query cond
      Urethral Cancer
      query disease state id
      ds-urethral-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      source json pointer
      /studies/2/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      4cca71b1bddbfc917718e3b7fe169199952248da20bc074a512cd5846eb03232

    Preserved source evidence · Not medical advice