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FOcal RECurrent Assessment and Salvage Treatment (FORECAST)

This study is currently recruiting participants.
Verified May 2017 by Hashim Uddin Ahmed, University College London Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01883128
First Posted: June 21, 2013
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hashim Uddin Ahmed, University College London Hospitals
  Purpose
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.

Condition Intervention Phase
Progression of Prostate Cancer Device: Whole Body MRI Procedure: Focal Salvage Therapy Procedure: MRI Targeted biopsies Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Whole-body MRI and Focal salvage therapy
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Resource links provided by NLM:


Further study details as provided by Hashim Uddin Ahmed, University College London Hospitals:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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)



Other Outcome Measures:
  • 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



Estimated Enrollment: 177
Actual Study Start Date: April 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883128


Contacts
Contact: Abi A Kanthabalan, MBChB +44(0)2034479194 ana-k@doctors.org.uk
Contact: Hashim U Ahmed, FRCS, PhD +44(0)2034479194 hashim.ahmed@ucl.ac.uk

Locations
United Kingdom
Hampshire Hospitals NHS Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: Richard Hindley, FRCS, MD       Richard.Hindley@hhft.nhs.uk   
Principal Investigator: Richard Hindley, FRCS, MD         
University College London Hospitals Recruiting
London, United Kingdom, NW1 2BU
Contact: Abi Kanthabalan    +44(0)34479194    abi-k@doctors.org.uk   
Principal Investigator: Hashim U Ahmed, FRCS, PhD         
Sponsors and Collaborators
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
  More Information

Responsible Party: Hashim Uddin Ahmed, MRC Clinician Scientist and Clinical Lecturer in Urology, University College London Hospitals
ClinicalTrials.gov Identifier: NCT01883128     History of Changes
Other Study ID Numbers: 1R01CA135089 ( U.S. NIH Grant/Contract )
First Submitted: June 18, 2013
First Posted: June 21, 2013
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Hashim Uddin Ahmed, University College London Hospitals:
Biochemical Failure
Radiotherapy
Radiorecurrent Prostate Cancer
MRI Prostate
Whole Body MRI
Bone Scan
Choline PET
Focal Salvage Treatment
HIFU
Cryotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases