FOcal RECurrent Assessment and Salvage Treatment

NCT ID: NCT01883128

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Whole Body MRI

Intervention Type: DEVICE

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

MRI Targeted Biopsies

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

Group Type: EXPERIMENTAL

MRI Targeted biopsies

Intervention Type: PROCEDURE

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

Focal Salvage Therapy

Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only

Group Type: EXPERIMENTAL

Focal Salvage Therapy

Intervention Type: PROCEDURE

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

Interventions

Whole Body MRI

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

Intervention Type: DEVICE

Focal Salvage Therapy

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Philips Ingenia 3.0T Magnetic Resonance System; CE0344; HIFU Device name: Sonablate 500; HIFU Device Serial Number 1049; Cryotherapy Device Name: Seed Net Gold; Cryotherapy Serial Number: Cat No FPRCH 2024; SmartTarget software for image-registration

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Hashim Uddin Ahmed

MRC Clinician Scientist and Clinical Lecturer in Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hashim U Ahmed, FRCS, PhD

Role: STUDY_CHAIR

University College London Hospitals

Manit Arya, FRCS

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Mark Emberton, FRCS, MD

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Shonit Punwani, FRCR

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Locations

Hampshire Hospitals NHS Trust

London, , United Kingdom

Site Status: RECRUITING

University College London Hospitals

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Abi A Kanthabalan, MBChB

Role: CONTACT

ana-k@doctors.org.uk

+44(0)2034479194

Hashim U Ahmed, FRCS, PhD

Role: CONTACT

hashim.ahmed@ucl.ac.uk

+44(0)2034479194

Facility Contacts

Richard Hindley, FRCS, MD

Role: primary

Richard.Hindley@hhft.nhs.uk

Abi Kanthabalan

Role: primary

abi-k@doctors.org.uk

+44(0)34479194

References

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.

Reference Type: DERIVED

PMID: 37778954 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37385981 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35370021 (View on PubMed)

Other Identifiers

1R01CA135089

Identifier Type: NIH

Identifier Source: org_study_id

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