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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: 16 French Foley Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Valerie P Powellfirstname.lastname@example.org|
|Contact: Andrew M McDonald, MDemail@example.com|
|United States, Alabama|
|Hazelrig-Salter Radiation Oncology Center||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Andrew M McDonald, MD||University of Alabama at Birmingham|