Imaging Biomarkers to Validate Response in Enzalutamide-T... | NCT02677376

NCT02677376

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description
2015-1174	Other Identifier	Institutional Review Board
A534260	Other Identifier	UW Madison
SMPH\MEDICINE\HEM-ONC	Other Identifier	UW Madison

Status Module

Name	Class
Prostate Cancer Foundation	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	Within 2 weeks of week 12

Eligibility Module

Eligibility 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).

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms