Prostate Cancer AdenocarcinomaPhase 2/3NCT03852654
18F-DCFPyL PET-CT Scan and Prostate Cancer
A Phase 2/3 study testing 18F-DCFPyL in people with Prostate Cancer Adenocarcinoma, run by Lida Jafari at 1 site in United States.
Trial summary
Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Adenocarcinoma
- What is being tested?
- 18F-DCFPyL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2018to 30 Jun 2020
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and male.
- Ability to understand the study and the willingness to sign a written informed consent document.
- Histologically confirmed adenocarcinoma of the prostate.
- PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
- Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
- Willing to comply with the procedural requirements of this protocol.
Who cannot join
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
- The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
- Primary small cell carcinoma of the prostate.
- Participation in this study significantly delay the scheduled standard of care therapy.
- Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
- The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
- Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Greater Los Angeles
Los Angeles, California, 90073
Lida Jafari, M.D.
About this study
Official title: A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer
Primary Objective:
The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging.
Secondary Objectives:
Frequency of the change in primary treatment plan after initial staging.
Read the detailed description
This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.
- Conditions
- Prostate Cancer Adenocarcinoma
- Being tested
- 18F-DCFPyL
- Keywords
- Prostate Cancer, PET CT scan, 18F-DCFPyL
- 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-DCFPyLDrug
Subjects with biopsy proven prostate cancer, no prior local therapy, and:
PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: 18F-DCFPyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start22 Jul 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer AdenocarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lida Jafari
- Sponsor type
- US federal agency
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Lida Jafari, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852654
- Sponsor's protocol ID
- Jafari0001
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03852654
- Acronym / sponsor ID
- Jafari0001
- Conditions
- Prostate Cancer Adenocarcinoma
- Keywords
- Prostate Cancer, PET CT scan, 18F-DCFPyL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Lida JafariUS federal agency
- Collaborators
- University of California, Los Angeles
- Study start
- 22 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Feb 2019 (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.
Primary Objective:
The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging.
Secondary Objectives:
Frequency of the change in primary treatment plan after initial staging.
Detailed description
This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: 18F-DCFPyL |
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)
- Age ≥ 18 years and male.
- Ability to understand the study and the willingness to sign a written informed consent document.
- Histologically confirmed adenocarcinoma of the prostate.
- PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
- Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
Key exclusion criteria (7 listed)
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
- The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
- Primary small cell carcinoma of the prostate.
- Participation in this study significantly delay the scheduled standard of care therapy.
- Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
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-DCFPyLSubjects with biopsy proven prostate cancer, no prior local therapy, and: PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan. | Drug | treatment |
Primary outcome
the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 18F-DCFPyL in people with Prostate Cancer Adenocarcinoma, run by Lida Jafari 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 7 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 25 Feb 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jafari Lida, M.D. (310 268 3583, lida.jafari@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging (time frame: 120 days). 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 25 Feb 2019.