Prostate CancerNCT03692104
US-CT Fusion for Post Implant Dosimetry
An observational study of Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- transrectal ultrasound
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.
Who may be able to join
- localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost
Who cannot join
- Unable to undergo MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy
Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.
Read the detailed description
25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.
- Conditions
- Prostate Cancer
- Being tested
- transrectal ultrasound
- Keywords
- prostate cancer, brachytherapy, Quality assurance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transrectal ultrasoundDiagnostic test
Use of US for post implant quality assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion
Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared
Measured: 1 month
Secondary outcomes (1)
Comparison of prostate volume assessed by 2 different imaging modalities
Assessment of prostate volume as contoured on US vs MRI post implant
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start3 Nov 2017
- Primary completion28 Feb 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
- Investigators
- Francois Bachand, MD, Study chair, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692104
- Sponsor's protocol ID
- H17-02634
- Status last verified
- Jan 2020
- First submitted
- 27 Sep 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy
- ClinicalTrials.gov ID
- NCT03692104
- Acronym / sponsor ID
- H17-02634
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, brachytherapy, Quality assurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.
Detailed description
25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.
Key inclusion criteria (1 listed)
- localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost
Key exclusion criteria (1 listed)
- Unable to undergo MRI
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 |
|---|---|---|
| transrectal ultrasoundUse of US for post implant quality assessment | Diagnostic test | – |
Primary outcome
Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion
Time frame: 1 month
Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared
1 secondary outcome
Comparison of prostate volume assessed by 2 different imaging modalities
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
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.
Francois Bachand, MD study chair
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 1 inclusion and 1 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 27 Jan 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion (time frame: 1 month). 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 27 Jan 2020.