FOcal RECurrent Assessment and Salvage Treatment

Trial Information

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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Accuracy of whole body MRI in identifying distant disease

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United Kingdom: University College London Hospitals

Study ID:

1R01CA135089

NCT ID:

NCT01883128

Start Date:

October 2015

Completion Date: