FOcal RECurrent Assessment and Salvage Treatment (FORECAST)
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ClinicalTrials.gov Identifier: NCT01883128 |
Recruitment Status
:
Recruiting
First Posted
: June 21, 2013
Last Update Posted
: May 10, 2017
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Condition or disease | Intervention/treatment | Phase |
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Progression of Prostate Cancer | Device: Whole Body MRI Procedure: Focal Salvage Therapy Procedure: MRI Targeted biopsies | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 177 participants |
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. |
Actual Study Start Date : | April 2014 |
Estimated Primary Completion Date : | October 2019 |
Estimated Study Completion Date : | October 2019 |

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.
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Device: Whole Body MRI
Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla
Other Names:
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Experimental: MRI Targeted Biopsies
Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies
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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
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Experimental: Focal Salvage Therapy
Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only
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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:
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- 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
- 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)
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy
- Biochemical failure as defined by the Phoenix criteria (PSA nadir + 2ng/ml)
- Men considering local salvage treatment for radio-recurrent disease
- Life expectancy of 5 years or more
Exclusion Criteria:
- Have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months
- Unable to have MRI scan as defined by standard care practice
- Metallic implant likely to cause artefact and reduce scan quality
- PSA doubling time of 3 months or less
- PSA value 20ng/ml or greater
- Prior prostate biopsies following biochemical failure
- 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)
- Unable to have general or regional anaesthesia
- Unable to give informed consent

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
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 |
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 |
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 |
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 Posted: | June 21, 2013 Key Record Dates |
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 |