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Metastatic Castration Resistant Prostate CancerBIOMETHSNCT02424448

Study to Determine the Feasibility, Evaluability and Variability in Markers of Drug Action in Castration Resistant Prostate Cancer

An observational study of Metastatic Castration Resistant Prostate Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsies, blood and urine samples
Type of treatment
Surgery or procedure
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2014to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Males (18+) with metastatic hormone refractory prostate cancer

Who may be able to join

  • Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy
  • Patients aged 18 years and older
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
  • Provision of archival tumour sample for PTEN status determination as directs group assignment
  • Provision of written informed consent
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  • Provision of cancer tissue samples, willing to undergo 1-3 biopsies on 2 separate occasions
  • No change of cancer treatment anticipated until final biopsy/ blood samples have been taken
  • Serum testosterone level <50 ng/dL sustained by medical or surgical castration

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrolment in the present study
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
  • Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection
  • Radiotherapy to lesion to be biopsied within 4 weeks of biopsy
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  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
  • Patients at increased risk of bleeding as a result of biopsy
  • History of bleeding disorders or thrombocytopenia (platelets <100)
  • Concomitant treatment with anticoagulant therapy such as warfarin/low molecular weight heparin (Aspirin not contra-indicated but consider temporary cessation if biopsy site has higher risk of bleeding e.g. liver)
  • Current urinary tract infection (UTI) or prostatitis
  • Known infection with HIV, Hepatitis B or Hepatitis C

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: BIOMETHS Study. A Methodology Study to Determine the Feasibility, Evaluability and Temporal Variability in Candidate Pharmacodynamic Markers of Drug Action in Castration Resistant Prostate Cancer

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.

Read the detailed description

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.

Being tested
Biopsies, blood and urine samples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsies, blood and urine samplesProcedure or surgery

    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.

Study groups in NCT02424448
Study groupRoleWhat they receive
Metastatic CRPCPatients 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.
Receives: Procedure: Biopsies, blood and urine samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of formalin fixed cancer tissue samples evaluable for immunohistochemical analysis

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  2. Baseline levels of biomarkers in formalin fixed cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  3. Intra-lesion temporal variability between formalin fixed cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  4. Intra-lesion spatial variability between formalin fixed cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

Secondary outcomes (4)

  1. Percentage of frozen cancer tissue samples evaluable for biomarker analysis

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  2. Baseline levels of biomarkers in frozen cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  3. Intra-lesion temporal variability between frozen cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

  4. Intra-lesion spatial variability between frozen cancer tissue samples

    Measured: Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424448
Sponsor's protocol ID
CFTSp063 / 12_DOG04_145
Acronym
BIOMETHS
Status last verified
Jul 2016
First submitted
16 Apr 2015
Last updated
26 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Castration Resistant Prostate Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.

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