Prostate CancerNCT02225925
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
A study testing Brachytherapy in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and refine technical methods of using the system, as well as confirm its performance and accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 28 Feb 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, localized adenocarcinoma of the prostate
- Clinical stages T1b - T3a
- The patient has decided to undergo brachytherapy (or brachytherapy plus external beam radiation) as a treatment modality for his prostate cancer
- Karnofsky Performance Status > 60
- Prostate volume by transrectal ultrasound (TRUS) < 55 cc
- International Prostate symptom score (IPSS) 20 or less
- Ability to have Magnetic resonance imaging as part of post-implant assessment
- Signed study-specific consent form prior to registration
Who cannot join
- Stage T3b or greater disease.
- Prior history of pelvic radiation therapy
- Significant obstructive symptoms (IPSS greater than 20)
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
- Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
- Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
The SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound
The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and refine technical methods of using the system, as well as confirm its performance and accuracy.
Read the detailed description
The use of brachytherapy or implantation of radioactive sources into the prostate for adenocarcinoma has advantages over external beam radiation in that a very high dose can be delivered to the tumor while limiting the doses to the surrounding normal tissue (i.e., bowel and bladder). It is established that outcomes after treatment with brachytherapy are related to the technical quality of source placement within the gland. Accurate placement of the radioactive sources with achievement of optimum dose distributions within the prostate is key to the success of brachytherapy with regard to both killing tumor as well as minimizing toxicity.
Due to factors such as deformations of the prostate during needle insertion, needle deviation from intended path during insertion, prostatic edema from needle trauma, and relaxation of tissues as well as source migration after needle removal, the actual source positions upon completion of the procedure may fail to accurately match their intended placement, resulting in variations from the idealized dosimetric plan.
One way to overcome this complex problem is to have the capability of visualizing the sources once they are in the prostate and then continuously updating the dosimetric plan in real time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are quantitatively integrated to allow for real-time visualization of source positions intraoperatively. A prior Phase I study performed by this group evaluated a prototype version of this mechanism, resulting in the successful treatment of 6 patients with true intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was excellent, and the intraoperative doses predicted by the system more accurate than that predicted by the current standard method (ultrasound-based dosimetry).
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Being tested
- Brachytherapy
- Keywords
- brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Dynamic dosimetry brachytherapy | Experimental | Cohort treated with dynamic dosimetry brachytherapy Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure
Measured: at time of implantation procedure
Secondary outcomes (7)
Seed Reconstruction From Intra-operative Fluoroscopy
Number of patients with all seeds reconstructed from fluoroscopy
Measured: up to 30 days post-treatment
Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction
Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)
Measured: 30 days post-treatment
Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater
Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater
Measured: 30 days post-treatment
Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry
Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry
Measured: Treatment - 30 days
Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema
Measured: Treatment - 30 days
Quality of Life (QoL) Assessments
Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)
Measured: baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5
Prostate Specific Antigen (PSA) Outcomes
PSA biochemical failure-free survival at last follow-up visit
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start1 Oct 2014
- Primary completionDec 2016
- Study completion28 Feb 2023
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny Song, M.D., Principal investigator, The SKCCC at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225925
- Sponsor's protocol ID
- J13164
- Other IDs
- NA_00091766
- Status last verified
- Mar 2023
- First submitted
- 8 Apr 2014
- Last updated
- 13 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound
- ClinicalTrials.gov ID
- NCT02225925
- Acronym / sponsor ID
- J13164
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Keywords
- brachytherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and refine technical methods of using the system, as well as confirm its performance and accuracy.
Detailed description
The use of brachytherapy or implantation of radioactive sources into the prostate for adenocarcinoma has advantages over external beam radiation in that a very high dose can be delivered to the tumor while limiting the doses to the surrounding normal tissue (i.e., bowel and bladder). It is established that outcomes after treatment with brachytherapy are related to the technical quality of source placement within the gland. Accurate placement of the radioactive sources with achievement of optimum dose distributions within the prostate is key to the success of brachytherapy with regard to both killing tumor as well as minimizing toxicity.
Due to factors such as deformations of the prostate during needle insertion, needle deviation from intended path during insertion, prostatic edema from needle trauma, and relaxation of tissues as well as source migration after needle removal, the actual source positions upon completion of the procedure may fail to accurately match their intended placement, resulting in variations from the idealized dosimetric plan.
One way to overcome this complex problem is to have the capability of visualizing the sources once they are in the prostate and then continuously updating the dosimetric plan in real time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are quantitatively integrated to allow for real-time visualization of source positions intraoperatively. A prior Phase I study performed by this group evaluated a prototype version of this mechanism, resulting in the successful treatment of 6 patients with true intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was excellent, and the intraoperative doses predicted by the system more accurate than that predicted by the current standard method (ultrasound-based dosimetry).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic dosimetry brachytherapy | Experimental | Radiation: BrachytherapyCohort treated with dynamic dosimetry brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed, localized adenocarcinoma of the prostate
- Clinical stages T1b - T3a
- The patient has decided to undergo brachytherapy (or brachytherapy plus external beam radiation) as a treatment modality for his prostate cancer
- Karnofsky Performance Status > 60
- Prostate volume by transrectal ultrasound (TRUS) < 55 cc
Key exclusion criteria (6 listed)
- Stage T3b or greater disease.
- Prior history of pelvic radiation therapy
- Significant obstructive symptoms (IPSS greater than 20)
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
- Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
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 |
|---|---|---|
| Brachytherapy | Radiation | Dynamic dosimetry brachytherapy |
Primary outcome
Procedure Time
Time frame: at time of implantation procedure
Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure
7 secondary outcomes
Seed Reconstruction From Intra-operative Fluoroscopy
Time frame: up to 30 days post-treatment
Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction
Time frame: 30 days post-treatment
Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater
Time frame: 30 days post-treatment
Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry
Time frame: Treatment - 30 days
Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema
Time frame: Treatment - 30 days
Quality of Life (QoL) Assessments
Time frame: baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5
Prostate Specific Antigen (PSA) Outcomes
Time frame: up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Danny Song, M.D. principal investigator
The SKCCC at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 13 Mar 2023. 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 25 Feb 2020). 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?
Procedure Time (time frame: at time of implantation procedure). 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 13 Mar 2023.