An observational study in Prostatic Neoplasms, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by University of Wisconsin, Madison · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 7 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Men ≥18 years with progressive, bone-metastatic castrate-resistant prostate cancer who will be treated with enzalutamide will be enrolled.
Exclusion Criteria:
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).
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.
Time frame: 12 weeks
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
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
To compare NaF PET/CT non-responding lesions to known resistance molecular biomarkers obtained from biopsy of non-responding lesions
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.
To determine NaF PET/CT -derived radiomic profiles that correlate with prolonged benefit (PFS \> 12 month) to enzalutamide
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
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
Time frame: Within 2 weeks of week 12
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison