FOcal RECurrent Assessment and Salvage Treatment

NCT01883128 | Unknown Phase 2 DMC

• 1 other identifier: 1R01CA135089
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Progression of Prostate Cancer

Keywords

Biochemical Failure; Radiotherapy; Radiorecurrent Prostate Cancer; MRI Prostate; Whole Body MRI; Bone Scan; Choline PET; Focal Salvage Treatment; HIFU; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Accuracy of whole body MRI in identifying distant disease

  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 Outcomes (1)

• Can multiparametric MRI accurately detect localised recurrent prostate cancer

  2 years

Other Outcomes (1)

• To determine urinary incontinence rates after focal salvage therapy to localised recurrent prostate cancer?

  2 years

Study Arms (3)

Whole body MRI

EXPERIMENTAL

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

MRI Targeted Biopsies

EXPERIMENTAL

Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies

Procedure: MRI Targeted biopsies

Focal Salvage Therapy

EXPERIMENTAL

Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only

Procedure: Focal Salvage Therapy

Interventions

Whole Body MRI DEVICE

Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla

Also known as: Philips Ingenia 3.0T Magnetic Resonance System, CE0344

Whole body MRI

Focal Salvage Therapy PROCEDURE

Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.

Also known as: HIFU Device name: Sonablate 500, HIFU Device Serial Number 1049, Cryotherapy Device Name: Seed Net Gold, Cryotherapy Serial Number: Cat No FPRCH 2024

Focal Salvage Therapy

MRI Targeted biopsies PROCEDURE

Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally

Also known as: SmartTarget software for image-registration

MRI Targeted Biopsies

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (2)

Hampshire Hospitals NHS Trust

London, NW1 2BU, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2BU, United Kingdom

RECRUITING

Related Publications (3)

• Light A, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Emara A, Haroon A, Latifoltojar A, Sidhu H, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra AV, Bomanji J, Winkler M, Horan G, Moore CM, Emberton M, Punwani S, Ahmed HU, Shah TT. The Role of Multiparametric MRI and MRI-targeted Biopsy in the Diagnosis of Radiorecurrent Prostate Cancer: An Analysis from the FORECAST Trial. Eur Urol. 2024 Jan;85(1):35-46. doi: 10.1016/j.eururo.2023.09.001. Epub 2023 Sep 29.

  PMID: 37778954 DERIVED

• Light A, Peters M, Reddy D, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Emara A, Haroon A, Latifoltojar A, Sidhu H, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra AV, Bomanji J, Winkler M, Horan G, Moore C, Emberton M, Punwani S, Ahmed HU, Shah TT. External validation of a risk model predicting failure of salvage focal ablation for prostate cancer. BJU Int. 2023 Nov;132(5):520-530. doi: 10.1111/bju.16102. Epub 2023 Jun 29.

  PMID: 37385981 DERIVED

• Shah TT, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Grierson J, Miah H, Emara A, Haroon A, Latifoltojar A, Sidhu H, Clemente J, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra A, Bomanji J, Winkler M, Horan G, Moore CM, Emberton M, Punwani S, Ahmed HU. Magnetic Resonance Imaging and Targeted Biopsies Compared to Transperineal Mapping Biopsies Before Focal Ablation in Localised and Metastatic Recurrent Prostate Cancer After Radiotherapy. Eur Urol. 2022 Jun;81(6):598-605. doi: 10.1016/j.eururo.2022.02.022. Epub 2022 Mar 31.

  PMID: 35370021 DERIVED

Study Officials

• Hashim U Ahmed, FRCS, PhD

  University College London Hospitals

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abi A Kanthabalan, MBChB

CONTACT

+44(0)2034479194; ana-k@doctors.org.uk

Hashim U Ahmed, FRCS, PhD

CONTACT

+44(0)2034479194; hashim.ahmed@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MRC Clinician Scientist and Clinical Lecturer in Urology

Model Details: Whole-body MRI and Focal salvage therapy

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: April 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

GB (2)