Adenocarcinoma of the ProstateNCT02523924
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
A study testing 18F-DCFPyL in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- 18F-DCFPyL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2015to 4 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- History of adenocarcinoma of the prostate treated with radical prostatectomy
- Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
- Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment
Who cannot join
- Intention to enroll in a blinded therapeutic clinical trial
- History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.
Read the detailed description
18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- 18F-DCFPyL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDrug
18F-DCFPyL PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL PET/CT | Experimental | Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT Receives: Drug: 18F-DCFPyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Measured: 6 months
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Measured: 6 months
Secondary outcomes (3)
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.
Measured: 6 months
Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Measured: 6 months
Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start2 Jun 2015
- Primary completion4 Nov 2016
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523924
- Sponsor's protocol ID
- J1545
- Other IDs
- IRB00062296
- Status last verified
- Jan 2020
- First submitted
- 28 May 2015
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02523924
- Acronym / sponsor ID
- J1545
- Conditions
- Adenocarcinoma of the Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.
Detailed description
18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.
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 PET/CT | Experimental | Drug: 18F-DCFPyLMen with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- History of adenocarcinoma of the prostate treated with radical prostatectomy
- Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
- Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment
Key exclusion criteria (2 listed)
- Intention to enroll in a blinded therapeutic clinical trial
- History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)
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-DCFPyL18F-DCFPyL PET/CT | Drug | 18F-DCFPyL PET/CT |
Primary outcome
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Time frame: 6 months
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Time frame: 6 months
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
3 secondary outcomes
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
Time frame: 6 months
Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
Time frame: 6 months
Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing 18F-DCFPyL in people with Adenocarcinoma of the Prostate, 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 4 inclusion and 2 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 31 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 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?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT (time frame: 6 months). The study lists 2 primary outcomes in all. 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 31 Jan 2020.