An observational study in Metastatic Castration Resistant Prostate Cancer, sponsored by The Christie NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-26.
Sponsored by The Christie NHS Foundation Trust · Observational
This is a biopsy feasibility study in which patients with castration resistant prostate cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and de novo), blood samples, a urine specimen and clinical data for research.
The study aims to determine the feasibility of sampling and evaluability of biomarkers in CRPC tissue samples and circulating tumour cells (CTCs). Exploratory biomarker analysis may include, but will not be limited to, understanding the potential proof of mechanism (POM), proof of principle (POP) or predictive biomarkers of response to potential therapeutic agents for CRPC patients, or factors that may influence the development of CRPC.
This study is predicated on the continued development of agents targeting the PI3K pathway such as AZD(AstraZeneca Drug)8186 (PI3Kb); AZD5363 (Akt) and AZD2014 (mTOR) and anti-hormonals which are expected to deliver benefit in the management of tumours dependent on PI3K signalling as a result of e.g. phosphatase and tensin homolog (PTEN) deficiency or androgen receptor activation.
Loss of PTEN is common in CRPC. Current data indicate that AZD8186 inhibits PI3K downstream signalling in PTEN deficient but not in PTEN proficient cells and hence POM and efficacy will need to be determined in tumours with PTEN protein loss. In future studies, paired biopsy tumour tissue will be accessible for assessment of POM and PTEN status, either bone metastases lymph node metastases, or within the prostate tumour.
Recruitment of patients will be carried out in two stages as follows:
Stage 1 The first 10 eligible and consenting patients will be enrolled in the study and will undergo sequential biopsies. For all stage one participants, the PTEN status will be retrospectively determined from archival tumour samples by immuno-histochemistry (IHC).
The results of the PTEN analysis from Stage 1, will determine the number of patients in Stage 2 that must be PTEN positive or PTEN null. For this study the intent is to have equal numbers of each type i.e. ten PTEN positive and ten PTEN null.
Stage 2
In Stage 2, patients will be asked to sign a pre-screening consent form for their archival tumour sample to be analysed for PTEN status prior to undergoing any main study screening procedures. If their PTEN status matches one of the available slots they will be enrolled into the study.
Once a cohort reaches ten PTEN positive and ten PTEN null patients, it will close to recruitment.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 6 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Christie NHS Foundation Trust is the lead sponsor of 99 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Males (18+) with metastatic hormone refractory prostate cancer
Exclusion Criteria:
Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy. Patients will have biopsies, blood and urine samples taken.
Procedure: Biopsies, blood and urine samples
Session 1: Biopsies will be taken from the main study lesion and up to 2 metastatic sites at 1 visit or over 3 visits. Both formalin fixed and snap frozen material will be collected. At the session (i.e. once over the potential maximum of 3 visits in a session) a urine sample, blood samples for circulating tumour cells (CTC) and an exploratory blood sample (processed to plasma) will be taken. Session 2: 7 days +/-3 following the last biopsy taken from Session 1, repeat biopsies from the same tumour sites will be obtained. In cases where this is not possible, it is acceptable to biopsy alternative lesions. As in Session 1 biopsies may be taken at 1 visit or over 3 visits and urine, CTC blood samples and an exploratory blood sample (processed to plasma) will be taken.
Percentage of formalin fixed cancer tissue samples evaluable for immunohistochemical analysis
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Baseline levels of biomarkers in formalin fixed cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Intra-lesion temporal variability between formalin fixed cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Intra-lesion spatial variability between formalin fixed cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Percentage of frozen cancer tissue samples evaluable for biomarker analysis
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Baseline levels of biomarkers in frozen cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Intra-lesion temporal variability between frozen cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Intra-lesion spatial variability between frozen cancer tissue samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Intra-patient, inter-lesion variability (where possible) between samples
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
Percentage concordance between biomarker measurements on circulating tumour cells (CTCs) and tumour samples
(1 to 3 visits)
Time frame: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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The Christie NHS Foundation Trust