Clinical trial NCT02677376: Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC
Official title: Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2016-02-09
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: The percentage of biopsies obtained from NaF PET/CT- identified responding and non-responding bone metastases that contain tumor tissue from 30 patients
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: Within 2 weeks of week 12
measure: 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
timeFrame: Within 2 weeks of week 12
measure: Characterizations obtained from NaF PET/CT images from patients who demonstrate a progression free survival of greater than 12 months on enzalutamide treatment.
timeFrame: Within 2 weeks of week 12
measure: 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
timeFrame: Within 2 weeks of week 12
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: Principal Investigator
name: Glenn Liu
role: PRINCIPAL_INVESTIGATOR
References: