Prostatic CancerNCT04495959
Dynamic Whole Body PET/ MRI
An observational study of Prostatic Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return.Current conventional imaging modalities have limitations particularly at low prostate… Read more about this study
- Who is it for?
- Ages 19 to 99 years, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- 68Ga-HTK03149
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to Sep 2028
- 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 19 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed high risk prostate cancer (UCSF/CAPRA score of 6 or higher) who are scheduled to undergo radical prostatectomy.
Who may be able to join
- Subjects with biopsy-proven high risk prostate cancer (UCSF/CAPRA score 6 or higher) scheduled for radical prostatectomy.
- Able to not use the washroom for the duration of the dynamic imaging scanning.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Able to lie supine for the required duration of the scans
Who cannot join
- Meet the exclusion criteria for the appropriate standard of care imaging.
- Experience claustrophobia.
- Subjects with severe renal disease or acutely deteriorating renal function (eGRF<30 mL/min)
- Subjects may not take part in this study if they have a pacemaker, an implanted defibrillator, or certain other implanted electronic or metallic devices, shrapnel, or other metal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Whole Body Positron Emission Tomography/ Magnetic Resonance Imaging
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return.Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use 68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.
Read the detailed description
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-HTK03149 DWB PET/MRI to stage patients with high risk prostate cancer who will subsequently under go radical prostatectomy.
Eligible subjects will undergo a 68Ga-HTK03149 DWB PET/MRI at the University of British Columbia (UBC) - Vancouver, Djavad Mowafaghian Centre for Brain Health where the UBC PET/MRI is located. Each subject will receive a 18F-DCFPyL PET/MRI DWB scan at the UBC centre, as part of this research study. Each study subject will receive a bolus intravenous dose of 18F-DCFPyL. The subject will be placed on the PET/MRI scanner for a dynamic whole body PET scan. Then after a brief break off the scanner, they will return to the scanner for the standard whole body PET/MRI scan.
The PET/MRI scan will take approximately 3.5 hours of patient time above and beyond the time needed for standard of care.
Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.
Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-HTK03149. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-HTK03149. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-HTK03149 administration.
All subjects will be followed for 5 years following the 68Ga-HTK03149 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.
- Conditions
- Prostatic Cancer
- Being tested
- 68Ga-HTK03149
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HTK03149Drug
PET/MRI scan with radiotracer 68Ga-HTK03149
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-HTK03149 PET/MRI DWB scan | All participants will undergo the same procedures listed in "Detailed Description" in the protocol section. Receives: Drug: 68Ga-HTK03149 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.
Determination of sensitivity when compared with pathology reports
Measured: 5 years after 68Ga-HTK03149DWB PET/MRI scan
Secondary outcomes (2)
Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer
Comparison of parametric images derived from dynamic whole body PET imaging to conventional static PET images as well as MRI images . Assessment as to whether parametric images are able to distinguish normal organ accumulation (e.g. ureters, kidneys, bladder, bowel) from tumour uptake, based on the kinetics of radiotracer accumulation. Quantitative comparison of image contrast and signal-to-noise ratio (SNR) between static and parametric images from dynamic scans will be completed.
Measured: 5 years after 68Ga-HTK03149 DWB PET/MRI scan
Number of participants with self-reported 68Ga-HTK03149 related adverse event
Patients will be contacted by phone the day after the 68Ga-HTK03149PET/CT scan to see if they experienced any adverse events in the 12 hours following the 18F-DCFPyL injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
Measured: 12 hours post 68Ga-HTK03149 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Aug 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Why it stopped: Study never initiated, should have been removed prior to last update.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495959
- Sponsor's protocol ID
- H20-02418
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2020
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Whole Body Positron Emission Tomography/ Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04495959
- Acronym / sponsor ID
- H20-02418
- Conditions
- Prostatic Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never initiated, should have been removed prior to last update.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Aug 2020 (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.
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return.Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use 68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.
Detailed description
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-HTK03149 DWB PET/MRI to stage patients with high risk prostate cancer who will subsequently under go radical prostatectomy.
Eligible subjects will undergo a 68Ga-HTK03149 DWB PET/MRI at the University of British Columbia (UBC) - Vancouver, Djavad Mowafaghian Centre for Brain Health where the UBC PET/MRI is located. Each subject will receive a 18F-DCFPyL PET/MRI DWB scan at the UBC centre, as part of this research study. Each study subject will receive a bolus intravenous dose of 18F-DCFPyL. The subject will be placed on the PET/MRI scanner for a dynamic whole body PET scan. Then after a brief break off the scanner, they will return to the scanner for the standard whole body PET/MRI scan.
The PET/MRI scan will take approximately 3.5 hours of patient time above and beyond the time needed for standard of care.
Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.
Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-HTK03149. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-HTK03149. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-HTK03149 administration.
All subjects will be followed for 5 years following the 68Ga-HTK03149 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-HTK03149 PET/MRI DWB scan | – | Drug: 68Ga-HTK03149All participants will undergo the same procedures listed in "Detailed Description" in the protocol section. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed high risk prostate cancer (UCSF/CAPRA score of 6 or higher) who are scheduled to undergo radical prostatectomy.
Key inclusion criteria (4 listed)
- Subjects with biopsy-proven high risk prostate cancer (UCSF/CAPRA score 6 or higher) scheduled for radical prostatectomy.
- Able to not use the washroom for the duration of the dynamic imaging scanning.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Able to lie supine for the required duration of the scans
Key exclusion criteria (4 listed)
- Meet the exclusion criteria for the appropriate standard of care imaging.
- Experience claustrophobia.
- Subjects with severe renal disease or acutely deteriorating renal function (eGRF<30 mL/min)
- Subjects may not take part in this study if they have a pacemaker, an implanted defibrillator, or certain other implanted electronic or metallic devices, shrapnel, or other metal.
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 |
|---|---|---|
| 68Ga-HTK03149PET/MRI scan with radiotracer 68Ga-HTK03149 | Drug | 68Ga-HTK03149 PET/MRI DWB scan |
Primary outcome
Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.
Time frame: 5 years after 68Ga-HTK03149DWB PET/MRI scan
Determination of sensitivity when compared with pathology reports
2 secondary outcomes
Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer
Time frame: 5 years after 68Ga-HTK03149 DWB PET/MRI scan
Number of participants with self-reported 68Ga-HTK03149 related adverse event
Time frame: 12 hours post 68Ga-HTK03149 injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No. no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostatic 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jan 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer. (time frame: 5 years after 68Ga-HTK03149DWB PET/MRI scan). 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 8 Jan 2025.