The objective of this study is to evaluate the clinical validation of a sensitive molecular assay to detect the presence of wild-type (so-called *full-length*) and alternatively spliced variants (ARV) of the AR in enriched CTC of patients with CRPC…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The determination of the clinical relevance for the presence or absence of
androgen receptor splice variants in circulating tumour cells from patients
with CRPC (with or without previous taxane chemotherapy) is the primary
endpoint of this study.
Secondary outcome
NA
Background summary
The hypothesis is that in absence of the ligand-binding domain (LBD) of the
androgen receptor (AR) in circulating tumour cells (CTC) of patients with
castration-resistant prostate cancer (CRPC), new AR-targeted treatment
strategies (abiraterone acetate and enzalutamide) would lose their
effectiveness and that an a priori resistance would thus exist against these
drugs.
Study objective
The objective of this study is to evaluate the clinical validation of a
sensitive molecular assay to detect the presence of wild-type (so-called *full-
length*) and alternatively spliced variants (ARV) of the AR in enriched CTC of
patients with CRPC, with progression of disease, as defined by a confirmed
increase in serum prostate specific antigen (PSA) levels, imaging and/or
clinical criteria.
Study design
Via a non-interventional prospective clinical trial we wish to collect extra
blood samples on three time points (before treatment initiation, at treatment
response and eventually at progression) from patients with castration-resistant
prostate cancer (CRPC). In these blood samples the presence or absence of ARV
in CTC prior to AR-targeted therapy (i.e. abiraterone acetate or enzalutamide)
will be evaluated by targeted RT-qPCR, as a predictor of clinical benefit from
these AR-directed therapies.
Study burden and risks
NA
Oosterveldlaan 24
Wilrijk 2610
BE
Oosterveldlaan 24
Wilrijk 2610
BE
Listed location countries
Age
Inclusion criteria
1. Willing and able to provide written informed consent
2. Male and age >= 18 years
3. Histologically or cytologically confirmed adenocarcinoma of the prostate
4. Patients eligible to receive enzalutamide or abiraterone acetate as judged by the treating physician
5. Patients with or without prior chemotherapy regimens
Exclusion criteria
1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
2. Not willing to comply with the procedural requirements (extra blood draw) of this protocol.
3. Any criteria which renders patients ineligible for new AR-directed therapy (i.e. abiraterone acetate, enzalutamide).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53474.078.15 |