Prostate CancerNCT02856100
Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer
An observational study of Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging therapies for a spectrum of patients suffering from PCa. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F DCFPyL- Radiopharmaceutical
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to Jan 2020
- 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 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CRPC and planned treatment with evidence of metastases on conventional imaging modality (CIM) (CT and/or bone scan)
Who may be able to join
- Willing and able to provide written informed consent
- Age ≥ 18 years and male
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Patients starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone)
- Prior docetaxel-based chemotherapy is permitted but not required
- Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
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- Rising PSA over a minimum 1-week interval
- Radiographic progression in soft tissue and/or bone
- Ongoing androgen deprivation with serum testosterone < 50 ng/dL (< 1.7 nM)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Hemoglobin ≥ 90 g/L independent of transfusion
- Platelet count ≥ 100,000/μL
- Serum albumin ≥ 30 g/L
- Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
- Serum potassium ≥ 3.5 mmol/L
Who cannot join
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Abnormal liver functions consisting of any of the following:
- Serum bilirubin ≥ 1.5 x ULN (except for patients with documented Gilbert's disease)
- AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
- Active or symptomatic viral hepatitis or chronic liver disease
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- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
- Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 12 months
- Known brain metastasis
- History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of orally administered hormonal agents.
- Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.0) grade of ≤ 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
- Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of first administration of the hormonal agent.
- Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
- Not willing to comply with the procedural requirements of this protocol
- Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
- Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging therapies for a spectrum of patients suffering from PCa. In this study we will image patients with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical follow-up.
- Conditions
- Prostate Cancer
- Being tested
- 18F DCFPyL- Radiopharmaceutical
- 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- RadiopharmaceuticalDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with CRPC, evidence of metastases, planned treatment | Not described Receives: Drug: 18F DCFPyL- Radiopharmaceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT
Change in number of metastatic lesions detected from baseline standard of care conventional imaging (CT and Bone Scan) to 18F-DCFPyL PET/CT at 8-12 weeks post- anti-androgen therapy (standard of care)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start3 Aug 2016
- Primary completionJan 2019
- Study completionJan 2020
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Steven Rowe, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856100
- Sponsor's protocol ID
- J15232
- Other IDs
- IRB00082289
- Status last verified
- May 2020
- First submitted
- 2 Aug 2016
- Last updated
- 7 May 2020
- Results posted
- No
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
- Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02856100
- Acronym / sponsor ID
- J15232
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging therapies for a spectrum of patients suffering from PCa. In this study we will image patients with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPC, evidence of metastases, planned treatment | – | Drug: 18F DCFPyL- Radiopharmaceutical |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CRPC and planned treatment with evidence of metastases on conventional imaging modality (CIM) (CT and/or bone scan)
Key inclusion criteria (15 listed)
- Willing and able to provide written informed consent
- Age ≥ 18 years and male
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Patients starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone)
- Prior docetaxel-based chemotherapy is permitted but not required
Key exclusion criteria (17 listed)
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Abnormal liver functions consisting of any of the following:
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
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- Radiopharmaceutical | Drug | Patients with CRPC, evidence of metastases, planned treatment |
Primary outcome
Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT
Time frame: up to 2 years
Change in number of metastatic lesions detected from baseline standard of care conventional imaging (CT and Bone Scan) to 18F-DCFPyL PET/CT at 8-12 weeks post- anti-androgen therapy (standard of care)
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.
Steven Rowe, MD, PhD principal investigator
Johns Hopkins University
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 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 15 inclusion and 17 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.
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?
Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT (time frame: up to 2 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.