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Trial record 72 of 292 for:    Sodium Fluoride OR Duraphat

Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC

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ClinicalTrials.gov Identifier: NCT02677376
Recruitment Status : Suspended (Interim analysis)
First Posted : February 9, 2016
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Prostate Cancer Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Other: 18F-Sodium Fluoride (NaF)

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide
Actual Study Start Date : June 2016
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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 secon 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).


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    To compare NaF PET/CT responding lesions to known response molecular biomarkers obtained from biopsy of responding lesions

  2. 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 ]
    To compare NaF PET/CT non-responding lesions to known resistance molecular biomarkers obtained from biopsy of non-responding lesions

  3. 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 ]
    To determine NaF PET/CT -derived radiomic profiles that correlate with prolonged benefit (PFS > 12 month) to enzalutamide

  4. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men ≥18 years with progressive, bone-metastatic castrate-resistant prostate cancer who will be treated with enzalutamide will be enrolled.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677376


Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Prostate Cancer Foundation
Investigators
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Principal Investigator: Glenn Liu Principal Investigator

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02677376     History of Changes
Other Study ID Numbers: UW15052
P30CA014520 ( U.S. NIH Grant/Contract )
2015-1174 ( Other Identifier: IRB number )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents