Prostate CancerRAD1801NCT03458234
RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
A study testing 16 French Foley Catheter in people with Prostate Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 16 French Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- Life expectancy >10 years
- Age ≥ 19 years
- Subjects given written informed consent
Who cannot join
- >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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35233
About this study
Official title: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- 16 French Foley Catheter
- Keywords
- Focal therapy, Prostate cancer, SBRT, Intra-urethral transponder
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 French Foley CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 16 French Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Within 6 months of completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start28 Jan 2020
- Primary completion20 Apr 2023
- Study completion22 Jun 2023
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Andrew McDonald, University of Alabama at Birmingham
- Investigators
- Andrew M McDonald, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458234
- Sponsor's protocol ID
- IRB-300002183
- Other IDs
- 000521070
- Acronym
- RAD1801
- Status last verified
- May 2024
- First submitted
- 1 Mar 2018
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT03458234
- Acronym / sponsor ID
- RAD1801 / IRB-300002183
- Conditions
- Prostate Cancer
- Keywords
- Focal therapy, Prostate cancer, SBRT, Intra-urethral transponder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal SBRT with intra-urethral radiotransponder | Experimental | Device: 16 French Foley CatheterThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16 French Foley CatheterA 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. | Device | Focal SBRT with intra-urethral radiotransponder |
Primary outcome
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.
3 secondary outcomes
Assess Early Efficacy
Time frame: Within 6 months of completion of radiation therapy
Assess Late Toxicity
Time frame: Within 6 months of completion of radiation therapy
Assess Quality of Life
Time frame: Within 6 months of completion of radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M McDonald, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16 French Foley Catheter in people with Prostate Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.