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Metastatic Prostate CancerMAESTRONCT03934164

Molecular Stratification Profiling Protocol in Metastatic Castration Resistant Prostate Cancer (mCRPC) - MAESTRO

An observational study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a prospective, observational, molecular stratification profiling study. Patients with mCRPC who have received at least one standard treatment for mCRPC will be approached to participate in MAESTRO. Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
600 participants
Where
1 siteUnited Kingdom
Study dates
28 Nov 2019to Mar 2025
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: Participants will be recruited from participating sites in the UK. Potential participants will be identified and discussed in oncology clinics and Multi-Disciplinary Team (MDT) meetings.

Who may be able to join

  • Male aged ≥18 years.
  • Histologically confirmed metastatic castrate resistant adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL (<2.0 nM).
  • Confirmed metastatic disease on imaging.
  • Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or procedure to acquire tumour tissue AND previously collected tumour specimens from prior surgery or biopsy available for analyses. An mCRPC biopsy collected within 6-months of trial entry can be used instead of this fresh biopsy if available and passes laboratory quality control requirements.
  • Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.
  • The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.

Who cannot join

  • The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.
  • Any psychiatric illness/social situations that would limit compliance with study requirements.
  • Presence of any concurrent condition or situation, which, in the investigators opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.

Trial locations and contacts

1 site in 1 country.

Stephanie Burnett, BSc contact

02087224261

maestro-icrctsu@icr.ac.uk

Ajit Sarvadikar contact

maestro-icrctsu@icr.ac.uk

United Kingdom1 site, 1 recruiting

  • The Royal Marsden NHSFT

    Sutton, Surrey, SM2 5PT

    Johann de Bono

    Recruiting

Other trials in United Kingdom

About this study

Official title: MAESTRO: Molecular Stratification Profiling Protocol in Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study is a prospective, observational, molecular stratification profiling study. Patients with mCRPC who have received at least one standard treatment for mCRPC will be approached to participate in MAESTRO. Patients must have archival tumour available and be willing to undergo a fresh tumour biopsy for molecular analyses. Tumour tissue (archival and fresh), research blood samples and saliva will be sent to the central laboratory for analysis to identify molecular aberrations through targeted or broader molecular analyses (e.g. exome, transcriptome) and orthogonal assays (e.g. immunohistochemistry; digital droplet PCR). When the results are available, depending on patients choice, the results will be discussed. If significant results are indicated, patients will be recommended to have follow up with a cancer geneticist to discuss the implications of these results for their personal and family's health.

There is a safety follow up 30 days after collection of study biopsy or blood samples. Patients will also be followed up for overall survival and subsequent anticancer treatment every 6 monthly via medical notes or telephone calls.

Read the detailed description

This study is a prospective, observational, molecular stratification profiling study.

mCRPC patients who have received at least one standard treatment for mCRPC will be approached to participate in MAESTRO. Patients must have archival tumour available and be willing to undergo a fresh tumour biopsy for molecular analyses. Following consent to MAESTRO, tumour tissue (archival and fresh), along with the research blood samples and saliva sample will be sent to the central laboratory for analysis to identify molecular aberrations through targeted or broader genomic analyses (e.g. exome, transcriptome) and orthogonal assays (e.g. immunohistochemistry; digital droplet PCR).

Patients will not receive any treatment as part of MAESTRO. Results of the molecular characterisation will be provided to the treating investigator to be fed back to the patient, depending on patient's choice on disclosing the results.

The following research samples are collected under as part of this study:

  • Where available, excess archival tumour tissue from previous biopsies or routine surgical procedures will be retrospectively collected.
  • Fresh tissue specimens will be obtained for patients who are undergoing standard of care interventions OR patient will undergo a bone marrow biopsy or an ultrasound /CT guided tumour biopsy of a safely accessible lesion. Fresh tumour specimens will be processed and/or frozen.
  • Sequencing analysis of tissues will be done and results will be made available in real time. Clinically significant results will be disclosed to patients and their clinicians as per patient consent.
  • Research samples for blood, serum, plasma and saliva will be collected at the time of the biopsy.

Patients who elected (optional consent) to receive sequencing results regarding incidental clinically significant findings, will be referred for genetic counselling.

Keywords
prostate, molecular stratification
Medical subject headings
Prostatic Neoplasms

What is being measured

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

  1. Number of molecular aberrations in diagnostic archive and fresh mCRPC tissue

    The prevalence of molecular aberrations in diagnostic archive and fresh mCRPC will be calculated with 95% confidence intervals.

    Measured: 4-6 weeks

Secondary outcomes (5)

  1. Quantify the association between molecular aberrations and baseline prognostic characteristics

    The association between identified molecular aberrations and baseline characteristics, known to be prognostic factors, will be quantified. Associations will be determined using Fisher's exact test for categorical characteristics and for continuous characteristics either a Wilcoxon rank sum test or t test will be used depending on the results of normality testing.

    Measured: 4-6 weeks

  2. Changes in molecular aberrations

    Changes in the molecular features of tumour biopsies acquired at diagnosis and fresh mCRPC will be quantified to demonstrate any differences in the molecular aberrations within the same patient's tumour.

    Measured: 4-6 weeks

  3. Safety - Review of biopsy-related adverse events: occurrence of at least one grade 3 or 4 event

    All events experienced by patients related to study procedures (collection of a fresh biopsy or blood samples) will be recorded and graded using CTCAE version 5 criteria and specifically the occurrence of at least one grade 3 or 4 event. Adverse events will be summarised by grade according to the worst grade experienced. In addition, the most frequently observed AEs will be summarised. The overall proportion of patients experiencing at least one grade 3 or 4 event will be presented by study procedure.

    Measured: 30 days after study biopsy/blood collection

  4. Time to development of CRPC

    This is defined in whole days as the time from the date of diagnosis to the date of confirmed CRPC. The median time and interquartile range will be determined per molecular aberration. Analyses will be conducted per molecular aberration and will use the Kaplan-Meier method and Cox proportional hazard models. Analyses will adjust for known baseline characteristics and previous treatments received using multivariable Cox proportional hazard models.

    Measured: From the date of diagnosis to the date of confirmed mCRPC, through study completion, up to 5 years

  5. Overall Survival (OS)

    OS will be measured from the date of CRPC to the date of death (whatever the cause). Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up. Analyses will use the Kaplan Meier method and Cox proportional hazard models by molecular aberration. Multivariable Cox proportional hazard models will include established prognostic factors such as site of disease.

    Measured: From the date of confirmed CRPC to the date of death from any cause, , through study completion, up to 5 years

Timeline

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

  1. First posted1 May 2019
  2. Study start28 Nov 2019
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2025 (estimated)

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
Other
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03934164
Sponsor's protocol ID
ICR-CTSU/2016/10059
Acronym
MAESTRO
Status last verified
Jul 2020
First submitted
21 Dec 2018
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Institute of Cancer Research, United Kingdom 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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?

Results are not available in the source record.

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

Contact Stephanie Burnett, BSc (02087224261, maestro-icrctsu@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of molecular aberrations in diagnostic archive and fresh mCRPC tissue (time frame: 4-6 weeks). 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 NCT03934164.

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 23 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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