NCT01883128

FOcal RECurrent Assessment and Salvage Treatment

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Whole Body MRI	Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla
PROCEDURE	Focal Salvage Therapy	Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.
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

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2013-06-21
• Last updated: 2017-05-10

Locations

2 sites across 1 country: United Kingdom