Progression of Prostate CancerPhase 2FORECASTNCT01883128
FOcal RECurrent Assessment and Salvage Treatment
A Phase 2 study testing Whole Body MRI, Focal Salvage Therapy and MRI Targeted biopsies in people with Progression of Prostate Cancer, run by University College London Hospitals at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Progression of Prostate Cancer
- What is being tested?
- Whole Body MRI, Focal Salvage Therapy and MRI Targeted biopsies
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2014to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Hampshire Hospitals NHS Trust
London, NW1 2BU
Richard Hindley, FRCS, MD, Richard.Hindley@hhft.nhs.uk
Richard Hindley, FRCS, MD
- Recruiting
University College London Hospitals
London, NW1 2BU
Abi Kanthabalan, +44(0)34479194, abi-k@doctors.org.uk
Hashim U Ahmed, FRCS, PhD
About this study
Official title: An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.
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
- Being tested
- Whole Body MRI, Focal Salvage Therapy, MRI Targeted biopsies
- Keywords
- Biochemical Failure, Radiotherapy, Radiorecurrent Prostate Cancer, MRI Prostate, Whole Body MRI, Bone Scan, Choline PET, Focal Salvage Treatment, HIFU, Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body MRIDevice
Also called Philips Ingenia 3.0T Magnetic Resonance System, CE0344
Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla
Focal Salvage TherapyProcedure or surgery
Also called HIFU Device name: Sonablate 500, HIFU Device Serial Number 1049, Cryotherapy Device Name: Seed Net Gold, Cryotherapy Serial Number: Cat No FPRCH 2024
Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.
MRI Targeted biopsiesProcedure or surgery
Also called SmartTarget software for image-registration
Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Whole Body MRI |
| MRI Targeted Biopsies | Experimental | Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies Receives: Procedure: MRI Targeted biopsies |
| Focal Salvage Therapy | Experimental | Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only Receives: Procedure: Focal Salvage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Can multiparametric MRI accurately detect localised recurrent prostate cancer
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Progression of Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Whole-body MRI and Focal salvage therapy
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Uddin Ahmed, University College London Hospitals
- Investigators
- Hashim U Ahmed, FRCS, PhD, Study chair, University College London HospitalsManit Arya, FRCS, Principal investigator, University College London HospitalsMark Emberton, FRCS, MD, Principal investigator, University College London HospitalsShonit Punwani, FRCR, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883128
- Sponsor's protocol ID
- 1R01CA135089
- Acronym
- FORECAST
- Status last verified
- May 2017
- First submitted
- 18 Jun 2013
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37778954Light 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.
PubMed 37385981Shah 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.
PubMed 35370021
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01883128
- Acronym / sponsor ID
- FORECAST / 1R01CA135089
- Conditions
- Progression of Prostate Cancer
- Keywords
- Biochemical Failure, Radiotherapy, Radiorecurrent Prostate Cancer, MRI Prostate, Whole Body MRI, Bone Scan, Choline PET, Focal Salvage Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Whole-body MRI and Focal salvage therapy
| Arm | Type | Receives |
|---|---|---|
| Whole body MRI | Experimental | Device: Whole Body MRIComparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan. |
| MRI Targeted Biopsies | Experimental | Procedure: MRI Targeted biopsiesTransperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies |
| Focal Salvage Therapy | Experimental | Procedure: Focal Salvage TherapyFocal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body MRIAlso: Philips Ingenia 3.0T Magnetic Resonance System, CE0344Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla | Device | Whole body MRI |
| Focal Salvage TherapyAlso: HIFU Device name: Sonablate 500, HIFU Device Serial Number 1049, Cryotherapy Device Name: Seed Net Gold, Cryotherapy Serial Number: Cat No FPRCH 2024Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue. | Procedure or surgery | Focal Salvage Therapy |
| MRI Targeted biopsiesAlso: SmartTarget software for image-registrationImage registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally | Procedure or surgery | MRI Targeted Biopsies |
Primary outcome
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
1 secondary outcome
Can multiparametric MRI accurately detect localised recurrent prostate cancer
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 37778954Light 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.
- Derived from this study: PubMed 37385981Light 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.
- Derived from this study: PubMed 35370021Shah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim U Ahmed, FRCS, PhD study chair
University College London Hospitals
Manit Arya, FRCS principal investigator
University College London Hospitals
Mark Emberton, FRCS, MD principal investigator
University College London Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole Body MRI, Focal Salvage Therapy and MRI Targeted biopsies in people with Progression of Prostate Cancer, run by University College London Hospitals at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abi A Kanthabalan, MBChB (+44(0)2034479194, ana-k@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of whole body MRI in identifying distant disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883128, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.