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Prostate CancerRECONCILENCT04340245

Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors

An observational study of Prostate Cancer, run by University College, London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study seeks to analyse MRI images and biological samples from 60 men diagnosed as having intermediate risk prostate cancer at baseline and one year afterwards to compare the molecular, genetic and transcriptomic differences between cancers that progress and cancers which do not. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
NA (Observational)
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
1 Jul 2020to 1 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Adult, Older adult

Study population: Men over the age of 18 with prostate cancer (Gleason 3+4) who are on active surveillance.

Who may be able to join

  • Male aged 18 years or above.
  • Diagnosed with prostate cancer within 4 months of entry.
  • Likert or PIRADS score greater than or equal to 4.
  • PSA less than or equal to 15 ng.ml-1 in the last 6 months.
  • mpMRI concordant with histology.
  • Overall Gleason score 7 (3+4).
  • Maximum cancer core length less than or equal to 10mm.
  • Patients on active surveillance

Who cannot join

  • Any contraindication to MRI scans (e.g. metal implants, unmanageable claustrophobia)
  • Presence of a pacemaker
  • Presence of a hip replacement
  • Any hormonal treatment or inhibitors of 5 alpha-reductase in the previous 6 months
  • Any previous TURP or other prostate surgery.
  • Previous treatment for prostate cancer.
Show all 9Show fewer
  • Patients who have previously had sepsis due to a prostate biopsy
  • Patients receiving concomitant treatment for their cancer
  • Inability to provide full informed consent (e.g. due to dementia)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College Hospital

    London

Other trials in United Kingdom

About this study

This study seeks to analyse MRI images and biological samples from 60 men diagnosed as having intermediate risk prostate cancer at baseline and one year afterwards to compare the molecular, genetic and transcriptomic differences between cancers that progress and cancers which do not.

Read the detailed description

RECONCILE is a single centre, prospective, longitudinal observational cohort study. 60 consenting men with intermediate risk, gleason 3+4, prostate cancer under active surveillance will be recruited to the study. They will undergo blinded, concurrent molecular and radiological analysis of their cancer at baseline and at one year. Tests at baseline and one year will include mpMRI, targeted prostate biopsy and further tissue sampling (semen, urine and blood). There will be PSA monitoring at 3 monthly intervals throughout the study as per standard of care active surveillance. Tissue will be analysed for biological and molecular markers significantly associated with radiological progression events.

After consenting to taking part in the study a patient will come in for an MRI scan as standard of care. This scan will be used at a subsequent visit to inform a guided trans-perineal biopsy. At this biopsy visit patients will provide research blood samples, a urine sample and have a confirmatory biopsy. After the standard of care diagnostic tissue samples are taken, three research tissue samples will be taken.

If the patient has been identified through the ReIMAGINE study and consents to take part in RECONCILE then these baseline visits are not needed, the data from ReIMAGINE will be used as the baseline visit data.

The patient will come in as scheduled for their regular PSA visits in line with their active surveillance protocol. If a PSA test shows signs of potential progression the patient will have a standard of care diagnostic MRI, if this confirms progression then the imaging and biopsy visits scheduled for one year will be triggered early.

In the absence of any identified progression the patient will return after 12 months and have both the imaging and biopsy visits repeated (again providing blood and urine). After this visit the patient will be considered as having finished the study.

Patients who consent to take part in the study who have previously taken part in the PLiS semen donation study will be asked to provide a semen sample before the one year biopsy visit for comparison with the baseline sample that was provided for the PLiS study.

Conditions
Prostate Cancer
Being tested
NA (Observational)
Keywords
MRI, MRI progression, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • NA (Observational)Other

    No interventions will be carried out. Comparisons will be made between patients whose cancer has progressed over the course of one year and patients whose cancer hasn't.

What is being measured

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

  1. Proportion

    Proportion of concordant pairs molecular progressor- radiological progressor.

    Measured: 12 months

Secondary outcomes (20)

  1. Progression time

    Time to radiological progression

    Measured: 12 months

  2. Lesion imaging characteristics

    Quantitative and qualitative imaging characteristics of MRI lesions

    Measured: 12 months

  3. Prostate imaging changes - quantitative

    Quantitative imaging features (MRI and derivative) of MRI lesions(s), a radiological progression ring (if present) and the rest of the prostate at different time points

    Measured: 12 months

  4. Prostate imaging changes - qualitative

    Qualitative imaging features (MRI and derivative) of MRI lesion(s), a radiological progression ring (if present) and the rest of the prostate at different time points.

    Measured: 12 months

  5. Imaging characteristics comparison

    Quantitative imaging characteristics of MRI lesion(s), a radiological progression ring (if present) and the rest of the prostate at different time points and stratify by radiological progressors vs non progressors.

    Measured: 12 months

  6. Histology

    Qualitative and quantitative histologic composition of cancer and surrounding tissues

    Measured: 12 months

  7. Heterogeneity

    Histologic heterogeneity of cancer, both qualitatively and quantitatively

    Measured: 12 months

  8. Molecular index

    Molecular Index of cancer, peritumoral and normal tissue.

    Measured: 12 months

  9. Urine and semen biomarkers

    Next generation sequencing will be used to perform urinary and seminal genome, exosome, methylome and transcriptome analysis in order to identify novel molecular signatures associated with prostate cancer imaging endotypes. No commercial biomarkers will be assessed within this study.

    Biomarker definition (NIH NCI dictionary) A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.

    Measured: 12 months

  10. Inflammatory infiltrate

    Qualitative and quantitative analysis of inflammatory infiltrate in cancer, peritumoral and normal tissue.

    Measured: 12 months

  11. Blood biomarkers

    Deep sequencing of circulating plasma DNA will be be used to explore novel prostate cancer biomarkers. Analysis of circulating inflammatory and immune markers including T-cell analysis will be used to correlate immunological biomarkers with prostate cancer endotypes.

    Measured: 12 months

  12. Immune pathways

    Qualitative and quantitative analysis of immune related pathways

    Measured: 12 months

  13. Transition to active treatment

    Proportion of patients who transition to active treatment, by time and type of treatment.

    Measured: 12 months

  14. Treatment eligibility

    Proportion of patients eligible to a type of treatment at baseline and follow-up.

    Measured: 12 months

  15. Rate of metastasis

    Rate of metastasis for prostate cancer at different time point.

    Measured: 12 months

  16. Concordance, histology and imaging

    Concordance rate between progression at histology and imaging.

    Measured: 12 months

  17. Concordance, radiology

    Concordance rate between radiologist for PRECISE scoring.

    Measured: 12 months

  18. Patient reported outcomes - EPIC 26

    Patient reported outcomes at different time points using the RPIC 26 questionnaire

    Measured: 12 months

  19. Patient reported outcomes - EORTC-QLQ-C30

    Patient reported outcomes at different time points using the EORTC-QLQ-C30 questionnaire

    Measured: 12 months

  20. Patient reported outcomes - MAX-PC

    Patient reported outcomes at different time points using the MAX-PC questionnaire

    Measured: 12 months

Timeline

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

  1. First posted9 Apr 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion1 Dec 2028 (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
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04340245
Sponsor's protocol ID
127742
Acronym
RECONCILE
Status last verified
Feb 2024
First submitted
21 Jan 2020
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared. Patients will be identified by a pseudo-anonymised patient number

Publications

  • Marsden T, Attard G, Punwani S, Giganti F, Freeman A, Haider A, Wingate A, Williams N, Syer T, Pashayan N, Moore CM, Emberton M, Orczyk C. The RECONCILE study protocol: Exploiting image-based risk stratification in early prostate cancer to discriminate progressors from non-progressors (RECONCILE). PLoS One. 2024 Oct 17;19(10):e0295994. doi: 10.1371/journal.pone.0295994. eCollection 2024.

    PubMed 39418289

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by University College, London 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 9 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2024. 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion (time frame: 12 months). 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 NCT04340245, which also lists 1 linked publication.

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 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.

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