Clinical trial NCT01883128: FOcal RECurrent Assessment and Salvage Treatment
Official title: An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 177
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Whole-body MRI and Focal salvage therapy
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Accuracy of whole body MRI in identifying distant disease
timeFrame: 2 years
Secondary outcomes:
measure: Can multiparametric MRI accurately detect localised recurrent prostate cancer
timeFrame: 2 years
Other outcomes:
measure: To determine urinary incontinence rates after focal salvage therapy to localised recurrent prostate cancer?
timeFrame: 2 years
Locations:
city: London
country: United Kingdom
facility: Hampshire Hospitals NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: University College London Hospitals
name: Hashim U Ahmed, FRCS, PhD
role: STUDY_CHAIR
affiliation: University College London Hospitals
name: Manit Arya, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Mark Emberton, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Shonit Punwani, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.