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

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Device: 16 French Foley Catheter

• Registration Number: NCT03458234
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Study Start: 2020-01-28
• Primary Completion: 2023-04-20
• Study Completion: 2023-06-22
• Results First Submitted: 2024-04-12
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Results First Posted: 2024-05-20
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal SBRT with intra-urethral radiotransponder	16 French Foley Catheter	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.

Primary Outcome Measures

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

Name	Time	Method
Assess Late Toxicity	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.
Assess Early Efficacy	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
Assess Quality of Life	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.

Trial Locations

Locations (1)

Hazelrig-Salter Radiation Oncology Center; 🇺🇸 Birmingham, Alabama, United States