Exploring the Mechanisms and Dynamics of Clonal Evolution Leading to Recurrence in Prostate Cancer
NCT ID: NCT04686188
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-11-26
2022-09-01
Brief Summary
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Cancer develops as a result of normal cells acquiring genetic mutations, and localised prostate cancer at diagnosis is commonly made up of different subclones - distinct regions within the patient's cancer with different sets of genetic mutations, each of which may behave differently and be more or less sensitive to treatments.
The IMRT clinical trial (CCR 1766) recruited 486 patients who received hormone therapy and radiotherapy to the prostate and lymph nodes in patients with locally advanced prostate cancer. The FORECAST study (FORecasting the Evolution of CAncer of the proState within a Trial) is undertaking genetic sequencing of several regions of these patients' prostate cancers in order to determine which subclones are present at diagnosis, and how they evolved. FORECAST also has permission to obtain and perform sequencing on primary samples from two other large trials in localized prostate cancer.
This study seeks to collect blood samples from patients who have experienced a recurrence in whom the primary biopsies have been sequenced as part of FORECAST. Additionally, blood will be collected from any patient in follow up at The Royal Marsden who received radiotherapy and hormone therapy for a localised prostate cancer and has experienced a recurrence but not yet started treatment. In these patients, the FORECAST protocol will be used to undertake genetic sequencing of their original prostate cancer biopsies. Genetic mutations from the cancer can be detected in the blood in patients who relapse, so-called 'liquid biopsies'. By comparing the genetic information between the primary and relapsed cancer, we can detect which subclones present at diagnosis are ultimately responsible for the cancer relapsing, and help us to understand the evolution of prostate cancers over time. This will assist us in predicting at the point of diagnosis which patients are more likely to relapse, so that we may consider escalating primary treatments or treating patients with high-risk subclonal mutations with targeted therapies upfront. As a result, we aim to reduce the number of patients treated for localised prostate cancer experiencing a recurrence. Additionally, although liquid biopsies are well-characterized in metastatic prostate cancer, little is known about their value in patients who have a biochemical-only relapse (patients who have a rising PSA with no evidence of cancer on scans) and this will also be explored.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Prostate tumour biopsy specimens available at The Royal Marsden Hospital, Kingston Hospital, Epsom and St Helier Hospitals, St George's Hospital or Croydon University Hospital and \>2 primary tumour regions sampled
3. Received primary radical radiotherapy and androgen deprivation therapy and remains under follow up at The Royal Marsden Hospital
4. Willing and able to comply with blood sample collection
5. Capable of understanding and complying with the protocol requirements and has given written, dated and signed informed consent AND
6. Confirmed biochemical or radiological evidence of recurrent prostate cancer, and not yet received treatment for recurrent disease OR
7. FORECAST patients with confirmed biochemical or radiological evidence of recurrent prostate cancer who have received or are currently receiving treatment but are progressing (rising PSA and/or evidence of progressive disease on imaging), or have a PSA \>2ng/ml
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Andrea Sottoriva, BSc MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research, United Kingdom
Locations
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Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Katharine C Webb, BSc MBBS MSc
Role: primary
Julia Murray, PhD FRCR
Role: backup
Other Identifiers
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275583
Identifier Type: OTHER
Identifier Source: secondary_id
CCR 5314
Identifier Type: -
Identifier Source: org_study_id