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

NCT03934164 | Unknown

• 1 other identifier: ICR-CTSU/2016/10059
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Prostate Cancer; Castration-resistant Prostate Cancer

Keywords

prostate; molecular stratification

Outcome Measures

Primary Outcomes (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.

  4-6 weeks

Secondary Outcomes (5)

• Quantify the association between molecular aberrations and baseline prognostic characteristics

  4-6 weeks

• Changes in molecular aberrations

  4-6 weeks

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

  30 days after study biopsy/blood collection

• Time to development of CRPC

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

• Overall Survival (OS)

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

Other Outcomes (2)

• Circulating Free DNA

  4-6 weeks

• Circulating Tumour Cells

  4-6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Prostate Cancer UK: collaborator

Study Sites (1)

The Royal Marsden NHSFT

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Johann de Bono

  The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Burnett, BSc

CONTACT

02087224261; maestro-icrctsu@icr.ac.uk

Ajit Sarvadikar

CONTACT

maestro-icrctsu@icr.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: May 1, 2019
• Study Start: November 28, 2019
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

GB (1)