Metastatic Prostate CancerPhase 1NCT03497377
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.
A Phase 1 study testing 18F-DCFPyL Injection and 18F-NaF in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- 18F-DCFPyL Injection and 18F-NaF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to Apr 2020
- Phase
- Phase 1
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of prostate cancer
- Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
- Rising PSA on two observations taken at least 1 week apart
- Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
- Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
- Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
- Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Who cannot join
- Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
- Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
- Serum creatinine > 3 times the upper limit of normal
- Total bilirubin > 3 times the upper limit of normal
- Liver Transaminases > 5times the upper limit of normal
- Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
- Prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- 18F-DCFPyL Injection, 18F-NaF
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyL InjectionDrug
18F-NaFDrug
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL Injection & 18F-NaF | Experimental | A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose Receives: Drug: 18F-DCFPyL Injection; Drug: 18F-NaF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT
Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging
Measured: 4 years
Secondary outcomes (1)
Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL
Compare proportion of new or progressive metastatic lesions found on NaF-PET/CT that are DCFPyL- PET/CT (or PET/MRI imaging if available) positive, and vice-versa.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start16 May 2016
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Martin Pomper, MD,PhD, Principal investigator, Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497377
- Sponsor's protocol ID
- J1559
- Other IDs
- IRB00065679, 1U01CA183031-01A1
- Status last verified
- May 2020
- First submitted
- 12 May 2016
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03497377
- Acronym / sponsor ID
- J1559
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 13 Apr 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.
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL Injection & 18F-NaF | Experimental | Drug: 18F-DCFPyL Injection, Drug: 18F-NaFA bolus of ~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological confirmation of prostate cancer
- Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
- Rising PSA on two observations taken at least 1 week apart
- Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
- Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
Key exclusion criteria (8 listed)
- Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
- Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
- Serum creatinine > 3 times the upper limit of normal
- Total bilirubin > 3 times the upper limit of normal
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 |
|---|---|---|
| 18F-DCFPyL Injection | Drug | 18F-DCFPyL Injection & 18F-NaF |
| 18F-NaF | Drug | 18F-DCFPyL Injection & 18F-NaF |
Primary outcome
Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT
Time frame: 4 years
Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging
1 secondary outcome
Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL
Time frame: 4 years
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 7 May 2020.
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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.
Martin Pomper, MD,PhD principal investigator
Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-DCFPyL Injection and 18F-NaF in people with Metastatic Prostate Cancer, 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 8 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 7 May 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT (time frame: 4 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 7 May 2020.