Prostate CancerNCT04809584
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
A study testing F18-DCFPyL, Gadolinium and Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- F18-DCFPyL, Gadolinium and Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- Patient is older than 18-year-old
- Biopsy proven prostate adenocarcinoma
- Planned prostatectomy with lymph node dissection
- Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
- Able to provide written consent
- Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Who cannot join
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
- Metallic implants (contraindicated for MRI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.
Read the detailed description
This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.
- Conditions
- Prostate Cancer
- Being tested
- F18-DCFPyL, Gadolinium, Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-DCFPyLDrug
Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL
GadoliniumDrug
Also called motexafin gadolinium
Contrast agent
Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) ScanProcedure or surgery
Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
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 Stanford UniversityThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei H Iagaru, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809584
- Sponsor's protocol ID
- IRB-58503
- Other IDs
- PROS0103, IRB-58503
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04809584
- Acronym / sponsor ID
- IRB-58503
- Conditions
- Prostate Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- First posted
- 22 Mar 2021 (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.
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.
Detailed description
This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is older than 18-year-old
- Biopsy proven prostate adenocarcinoma
- Planned prostatectomy with lymph node dissection
- Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
- Able to provide written consent
Key exclusion criteria (3 listed)
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
- Metallic implants (contraindicated for 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 |
|---|---|---|
| F18-DCFPyLParticipant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL | Drug | – |
| GadoliniumAlso: motexafin gadoliniumContrast agent | Drug | – |
| Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) ScanImaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
Andrei H Iagaru principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F18-DCFPyL, Gadolinium and Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan in people with Prostate Cancer, run by Stanford University 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Dec 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?
Results are not available in the source record.
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.
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 19 Dec 2024.