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| ID | Type | Description | Link |
|---|---|---|---|
| 000521070 | Other Grant/Funding Number | Varian Medical Systems |
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No longer manufacturing radiotransponder beacons. No similar product available. The results are no longer expected to have a scholarly or clinical impact. Terminating the study before it reaches its target accrual.
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal SBRT with intra-urethral radiotransponder | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16 French Foley Catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 6 months of completion of radiation therapy |
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Inclusion Criteria:
All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration
Karnofsky Performance Status (KPS) >70%.
Life expectancy >10 years
Age ≥ 19 years
Subjects given written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M McDonald, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hazelrig-Salter Radiation Oncology Center | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected. | Posted | 2 years |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew McDonald, MD; Principal Investigator | University of Alabama at Birmingham (UAB) | (205) 934-5670 | ammcdonald@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2020 | Apr 3, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Apr 3, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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. |
| 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. | Within 6 months of completion of radiation therapy |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | 5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected. | Posted | Within 6 months of completion of radiation therapy |
|
|
| Secondary | 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. | 5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected. | Posted | Within 6 months of completion of radiation therapy |
|
|
| Secondary | 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. | 5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected. | Posted | Within 6 months of completion of radiation therapy |
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|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |