An interventional study of 16 French Foley Catheter in Prostate Cancer, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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.
All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration
Exclusion Criteria:
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.
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.
Time frame: 2 years
Assess Early Efficacy
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
Time frame: Within 6 months of completion of radiation therapy
Assess Late Toxicity
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.
Time frame: Within 6 months of completion of radiation therapy
Assess Quality of Life
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.
Time frame: Within 6 months of completion of radiation therapy
| Milestone | Focal SBRT With Intra-urethral Radiotransponder |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Each participant was assessed at baseline, during time of treatment, and during follow-up at 3, 6, 9, 12, 18, and 24 months after completion of treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Focal SBRT With Intra-urethral Radiotransponder | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Focal SBRT With Intra-urethral Radiotransponder |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Focal SBRT With Intra-urethral Radiotransponder |
|---|---|
| Female | 0 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Focal SBRT With Intra-urethral Radiotransponder |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Focal SBRT With Intra-urethral Radiotransponder |
|---|---|
| United States | 5 |
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University of Alabama at Birmingham