Prostatic NeoplasmsNCT02677376
Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC
An observational study of Prostatic Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- 18F-Sodium Fluoride (NaF)
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2016to 3 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men ≥18 years with progressive, bone-metastatic castrate-resistant prostate cancer who will be treated with enzalutamide will be enrolled.
Who may be able to join
- Histologically proven adenocarcinoma of the prostate.
- Identifiable prostate cancer-related osseous metastases on bone scan or NaF PET/CT in the vertebral body, pelvis or other bone. Such lesions must be amenable to serial NaF PET/CT imaging. Preference will be given to subjects with multiple lesions that can be imaged in one image acquisition session to obtain maximal information as well as locations of lesions amenable to bone biopsies.
- Patients must be starting enzalutamide for treatment of metastatic castrate-resistant prostate, with cycle 1 day 1 occurring within 14 days after the first baseline NaF PET/CT. Subjects will be allowed to receive enzalutamide treatment on a concurrent study as long as the enzalutamide treatment study does not prohibit concurrent participation.
- Men of all races and ethnic groups of age ≥18 years.
- The effects of NaF on the developing human fetus are unknown. For this reason and because radiopharmaceuticals used for diagnostic imaging and other therapeutic agents and imaging procedures used in this trial may be or are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
- Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging and undergo bone biopsies.
- Patients must have both the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Known bleeding diathesis or on therapeutic anticoagulants (warfarin, low-molecular heparin, heparin analogues) that would increase risk of complications from bone biopsies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide
To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- 18F-Sodium Fluoride (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-Sodium Fluoride (NaF)Other
NaF is a tracer (dye) that will show changes to the cancer in bones. By using this tracer with PET/CT imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved. Participants will have a NaF PET/CT scan within 14 days prior to starting enzalutamide. All subjects will undergo a second NaF PET/CT scan after taking enzalutamide for 12 weeks. The NaF PET/CT obtained at week 12 will be compared to the first NaF PET/CT to identify a bone tumor that is responding (shrinking) and a bone tumor that is not responding (not shrinking).
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of biopsies obtained from NaF PET/CT- identified responding and non-responding bone metastases that contain tumor tissue from 30 patients
To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.
Measured: 12 weeks
Secondary outcomes (4)
The number of known response molecular biomarkers obtained from responding lesions as identified using NaF PET/CT in 30 patients who have received 12 weeks of enzalutamide.
To compare NaF PET/CT responding lesions to known response molecular biomarkers obtained from biopsy of responding lesions
Measured: Within 2 weeks of week 12
The number of patients whose biopsy tissue demonstrates at least 5 markers from a panel of 300 individual markers that have a moderate effect size of 1.0 or greater for the difference between the enzalutamide resistant and responding bone metastases
To compare NaF PET/CT non-responding lesions to known resistance molecular biomarkers obtained from biopsy of non-responding lesions
Measured: Within 2 weeks of week 12
Characterizations obtained from NaF PET/CT images from patients who demonstrate a progression free survival of greater than 12 months on enzalutamide treatment.
To determine NaF PET/CT -derived radiomic profiles that correlate with prolonged benefit (PFS > 12 month) to enzalutamide
Measured: Within 2 weeks of week 12
Comparison of the percentage of responding/non-responding lesions on NaF PET/CT to PSA response, RECIST response, time to PSA progressions and radiographic progression free survival
To correlate global responsiveness on NaF PET/CT (percentage of responding/non-responding lesions, SUVtotal) with clinical outcomes: PSA response, RECIST response, time to PSA progressions, and radiographic PFS
Measured: Within 2 weeks of week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start27 Jun 2016
- Primary completion30 Mar 2018
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Glenn Liu, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677376
- Sponsor's protocol ID
- UW15052
- Other IDs
- 2015-1174, A534260, SMPH\MEDICINE\HEM-ONC
- Status last verified
- Feb 2020
- First submitted
- 8 Jan 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide
- ClinicalTrials.gov ID
- NCT02677376
- Acronym / sponsor ID
- UW15052
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 9 Feb 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.
To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men ≥18 years with progressive, bone-metastatic castrate-resistant prostate cancer who will be treated with enzalutamide will be enrolled.
Key inclusion criteria (7 listed)
- Histologically proven adenocarcinoma of the prostate.
- Identifiable prostate cancer-related osseous metastases on bone scan or NaF PET/CT in the vertebral body, pelvis or other bone. Such lesions must be amenable to serial NaF PET/CT imaging. Preference will be given to subjects with multiple lesions that can be imaged in one image acquisition session to obtain maximal information as well as locations of lesions amenable to bone biopsies.
- Patients must be starting enzalutamide for treatment of metastatic castrate-resistant prostate, with cycle 1 day 1 occurring within 14 days after the first baseline NaF PET/CT. Subjects will be allowed to receive enzalutamide treatment on a concurrent study as long as the enzalutamide treatment study does not prohibit concurrent participation.
- Men of all races and ethnic groups of age ≥18 years.
- The effects of NaF on the developing human fetus are unknown. For this reason and because radiopharmaceuticals used for diagnostic imaging and other therapeutic agents and imaging procedures used in this trial may be or are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (2 listed)
- Known bleeding diathesis or on therapeutic anticoagulants (warfarin, low-molecular heparin, heparin analogues) that would increase risk of complications from bone biopsies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
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-Sodium Fluoride (NaF)NaF is a tracer (dye) that will show changes to the cancer in bones. By using this tracer with PET/CT imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved. Participants will have a NaF PET/CT scan within 14 days prior to starting enzalutamide. All subjects will undergo a second NaF PET/CT scan after taking enzalutamide for 12 weeks. The NaF PET/CT obtained at week 12 will be compared to the first NaF PET/CT to identify a bone tumor that is responding (shrinking) and a bone tumor that is not responding (not shrinking). | Other | – |
Primary outcome
The percentage of biopsies obtained from NaF PET/CT- identified responding and non-responding bone metastases that contain tumor tissue from 30 patients
Time frame: 12 weeks
To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.
4 secondary outcomes
The number of known response molecular biomarkers obtained from responding lesions as identified using NaF PET/CT in 30 patients who have received 12 weeks of enzalutamide.
Time frame: Within 2 weeks of week 12
The number of patients whose biopsy tissue demonstrates at least 5 markers from a panel of 300 individual markers that have a moderate effect size of 1.0 or greater for the difference between the enzalutamide resistant and responding bone metastases
Time frame: Within 2 weeks of week 12
Characterizations obtained from NaF PET/CT images from patients who demonstrate a progression free survival of greater than 12 months on enzalutamide treatment.
Time frame: Within 2 weeks of week 12
Comparison of the percentage of responding/non-responding lesions on NaF PET/CT to PSA response, RECIST response, time to PSA progressions and radiographic progression free survival
Time frame: Within 2 weeks of week 12
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 26 Feb 2020.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Glenn Liu principal investigator
Principal Investigator
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 Prostatic Neoplasms, run by University of Wisconsin, Madison 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 7 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 26 Feb 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?
The percentage of biopsies obtained from NaF PET/CT- identified responding and non-responding bone metastases that contain tumor tissue from 30 patients (time frame: 12 weeks). 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 26 Feb 2020.