FOcal RECurrent Assessment and Salvage Treatment (FORECAST)

May 8, 2017 updated by: Hashim Uddin Ahmed, University College London Hospitals

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

177

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals
        • Contact:
        • Principal Investigator:
          • Hashim U Ahmed, FRCS, PhD
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • Hampshire Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Richard Hindley, FRCS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy
  2. Biochemical failure as defined by the Phoenix criteria (PSA nadir + 2ng/ml)
  3. Men considering local salvage treatment for radio-recurrent disease
  4. Life expectancy of 5 years or more

Exclusion Criteria:

  1. Have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months
  2. Unable to have MRI scan as defined by standard care practice
  3. Metallic implant likely to cause artefact and reduce scan quality
  4. PSA doubling time of 3 months or less
  5. PSA value 20ng/ml or greater
  6. Prior prostate biopsies following biochemical failure
  7. Any prior local intervention to the prostate (e.g., laser/electrical resection or incision, cryotherapy, HIFU, any other ablative modality, any other radiotherapy, any other prostate injection therapy for symptoms or cancer control)
  8. Unable to have general or regional anaesthesia
  9. Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole body MRI
Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan.
Device: Whole Body MRI
Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla
Other Names:
  • Philips Ingenia 3.0T Magnetic Resonance System
  • CE0344
Experimental: MRI Targeted Biopsies
Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies
Procedure: MRI Targeted biopsies
Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally
Other Names:
  • SmartTarget software for image-registration
Experimental: Focal Salvage Therapy
Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only
Procedure: Focal Salvage Therapy
Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.
Other Names:
  • HIFU Device name: Sonablate 500
  • HIFU Device Serial Number 1049
  • Cryotherapy Device Name: Seed Net Gold
  • Cryotherapy Serial Number: Cat No FPRCH 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of whole body MRI in identifying distant disease
Time Frame: 2 years

Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests

- Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Can multiparametric MRI accurately detect localised recurrent prostate cancer
Time Frame: 2 years

Imaging of Local Disease

Transperineal multi-parametric MRI targeted biopsies compared to Template Prostate Mapping biopsies in the detection of UCL definition 2 clinically significant prostate cancer (Gleason >/=3+4 AND/OR Maximum Cancer Core Length >/=4mm in any one biopsy)
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine urinary incontinence rates after focal salvage therapy to localised recurrent prostate cancer?
Time Frame: 2 years

Treatment

Continence Presence of urinary incontinence (any pad usage) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Investigators

  • Study Chair: Hashim U Ahmed, FRCS, PhD, University College London Hospitals
  • Principal Investigator: Manit Arya, FRCS, University College London Hospitals
  • Principal Investigator: Mark Emberton, FRCS, MD, University College London Hospitals
  • Principal Investigator: Shonit Punwani, FRCR, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA135089 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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