Prostate Cancer RecurrentEXCERPTNCT04686188
Exploring the Mechanisms and Dynamics of Clonal Evolution Leading to Recurrence in Prostate Cancer
An observational study of Prostate Cancer Recurrent, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
Prostate cancer is the most common cancer in males in the UK, and current estimates are that 1 in 8 will be diagnosed with prostate cancer in their lifetime. Although surgery or radiotherapy with hormone therapy offers a good chance of cure in localised disease, recurrence can occur, which may cause significant… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2020to 1 Sep 2022
- 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: Patients will be recruited from outpatient prostate cancer follow up clinics at the Royal Marsden Hospital in Sutton, England.
Who may be able to join
- Male aged ≥18 years
- 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
- Received primary radical radiotherapy and androgen deprivation therapy and remains under follow up at The Royal Marsden Hospital
- Willing and able to comply with blood sample collection
- Capable of understanding and complying with the protocol requirements and has given written, dated and signed informed consent AND
- Confirmed biochemical or radiological evidence of recurrent prostate cancer, and not yet received treatment for recurrent disease OR
- 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
Who cannot join
- 1. Patients who have had another malignancy (excluding non-melanoma skin cancer, in-situ or superficial bladder cancer) treated within the previous 5 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Katharine C Webb, BSc MBBS MSc, +4420 8722 4504, katharine.webb@rmh.nhs.uk
Julia Murray, PhD FRCR, 02086613458, julia.murray@icr.ac.uk
About this study
Official title: Exploring the Mechanisms and Dynamics of Clonal Evolution Leading to Recurrence in Prostate Cancer Through Evaluation of Intratumour Heterogeneity at Diagnosis and Circulating Tumour DNA at Recurrence
Prostate cancer is the most common cancer in males in the UK, and current estimates are that 1 in 8 will be diagnosed with prostate cancer in their lifetime. Although surgery or radiotherapy with hormone therapy offers a good chance of cure in localised disease, recurrence can occur, which may cause significant distress, and may shorten the patient's life. In patients with locally advanced disease (disease that has broken through the surrounding capsule of the prostate gland), around 30-40% of patients experience a recurrence.
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.
Read more
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.
- Conditions
- Prostate Cancer Recurrent
- Keywords
- Prostate cancer, Liquid biopsy, Circulating tumor DNA, Intratumor Heterogeneity, Prostate radiotherapy, Recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the evolution of prostate cancers from localised disease to recurrence
This is a basic science/ translational study and therefore no strict pre-determined primary outcome can be defined as it is hypothesis-generating. This study aims to identify prognostic evolutionary or genetic biomarkers in localised prostate cancers and such biomarkers can then be evaluated further in clinical studies.
Measured: Until completion of study - predicted date 1 Sept 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start26 Nov 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrea Sottoriva, BSc MSc PhD, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686188
- Sponsor's protocol ID
- CCR 5314
- Other IDs
- 275583
- Acronym
- EXCERPT
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Fully anonymised DNA sequencing data will be stored in an online repository such as the European Genome- Phenome Archive at the European Bioinformatics Institute, or the forthcoming ICR (Institute of Cancer Research) repository. The data will be encrypted and accessible only to us unless a potential collaborator enters into an agreement with our group at the ICR and we agree to share the data as part of an ethically-approved study. No patient-identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanisms and Dynamics of Clonal Evolution Leading to Recurrence in Prostate Cancer Through Evaluation of Intratumour Heterogeneity at Diagnosis and Circulating Tumour DNA at Recurrence
- ClinicalTrials.gov ID
- NCT04686188
- Acronym / sponsor ID
- EXCERPT / CCR 5314
- Conditions
- Prostate Cancer Recurrent
- Keywords
- Prostate cancer, Liquid biopsy, Circulating tumor DNA, Intratumor Heterogeneity, Prostate radiotherapy, Recurrent prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is the most common cancer in males in the UK, and current estimates are that 1 in 8 will be diagnosed with prostate cancer in their lifetime. Although surgery or radiotherapy with hormone therapy offers a good chance of cure in localised disease, recurrence can occur, which may cause significant distress, and may shorten the patient's life. In patients with locally advanced disease (disease that has broken through the surrounding capsule of the prostate gland), around 30-40% of patients experience a recurrence.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from outpatient prostate cancer follow up clinics at the Royal Marsden Hospital in Sutton, England.
Key inclusion criteria (7 listed)
- Male aged ≥18 years
- 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
- Received primary radical radiotherapy and androgen deprivation therapy and remains under follow up at The Royal Marsden Hospital
- Willing and able to comply with blood sample collection
- Capable of understanding and complying with the protocol requirements and has given written, dated and signed informed consent AND
Key exclusion criteria (1 listed)
- 1. Patients who have had another malignancy (excluding non-melanoma skin cancer, in-situ or superficial bladder cancer) treated within the previous 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the evolution of prostate cancers from localised disease to recurrence
Time frame: Until completion of study - predicted date 1 Sept 2022
This is a basic science/ translational study and therefore no strict pre-determined primary outcome can be defined as it is hypothesis-generating. This study aims to identify prognostic evolutionary or genetic biomarkers in localised prostate cancers and such biomarkers can then be evaluated further in clinical studies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: No. Fully anonymised DNA sequencing data will be stored in an online repository such as the European Genome- Phenome Archive at the European Bioinformatics Institute, or the forthcoming ICR (Institute of Cancer Research) repository. The data will be encrypted and accessible only to us unless a potential collaborator enters into an agreement with our group at the ICR and we agree to share the data as part of an ethically-approved study. No patient-identifiable information will be shared.
Related trials for Prostate Cancer Recurrent
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Prostate Neoplasms, Prostatic Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Sottoriva, BSc MSc PhD principal investigator
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Recurrent, 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 7 inclusion and 1 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 28 Dec 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 Katharine C Webb, BSc MBBS MSc (+4420 8722 4504, katharine.webb@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the evolution of prostate cancers from localised disease to recurrence (time frame: Until completion of study - predicted date 1 Sept 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2020.