FDHT PET and Bicalutamide in Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02697032|
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Bicalutamide Procedure: FDHT PET||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||FDHT-PET to Visualize the Effect on the Androgen Receptor Level by Bicalutamide|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
At day 0 before start with bicalutamide, a FDHT-PET/CT will be performed, and one after 6 weeks (i.e. 2 weeks after steady-state). The second FDHT-PET will be performed to determine if this scan can be used as a biomarker for early response. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered.
Other Name: casodex
Procedure: FDHT PET
Other Name: 18F-FDHT PET
- quantify residual AR binding sites in metastatic breast cancer [ Time Frame: 6 weeks ]To quantify residual AR binding sites in metastatic breast cancer after 6 weeks of treatment with bicalutamide.
- determine whether changes in 18F-FDHT uptake [ Time Frame: 6 weeks ]To determine whether changes in 18F-FDHT uptake after 6 weeks associates with response to bicalutamide.
- Influence amount of AR tumor expression [ Time Frame: 6 weeks ]To determine whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression.
- Difference in changes in AR availability [ Time Frame: 6 weeks ]To determine whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide
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): NCT02697032
|Contact: Carolien P. Schröder, MD, PhDfirstname.lastname@example.org|
|Contact: Geke AP Hospers, MD, PhDemail@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: C. P. Schröder, MD, PhD +3150 3612821 firstname.lastname@example.org|
|Contact: G. A.P. Hospers, MD, PhD +31 50 3612821 email@example.com|
|Principal Investigator: C. P. Schröder, MD, PhD|
|Principal Investigator:||Carolien P. Schröder, MD, PhD||University Medical Center Groningen|