NCT02294903

Brief Summary

To assess the early histological outcomes of tissue ablation, adverse events and genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar device to treat localized prostate cancer in men with clinically significant prostate cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

November 15, 2014

Last Update Submit

April 23, 2018

Conditions

Prostate Cancer

Keywords

Focal radiofrequency ablationProstate cancerEncage

Outcome Measures

Primary Outcomes (1)

  • Cancer control outcome

    To determine the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer using coiled bipolar radiofrequency ablation (Encage)

    6 months

Study Arms (1)

ProRAFT

EXPERIMENTAL

Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation

Procedure: Coiled Bipolar Radiofrequency Ablation

Interventions

Coiled Bipolar Radiofrequency AblationPROCEDURE

Radiofrequency ablation by use of bipolar electrodes

ProRAFT

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven prostate cancer
  • A visible lesion on multiparametric Magnetic Resonance Imaging (mpMRI), that is accessible to a treatment based on radiofrequency bipolar electrodes
  • Transperineal prostate biopsies (template mapping and/or targeted) correlating with clinically significant lesion in the area of the Magnetic Resonance (MR)-visible lesion
  • Absence of clinically significant histological disease outside of the planned treatment zone
  • Radiological stage T1-T3aN0M0 disease, as determined by local guidelines
  • Serum prostate-specific antigen (serum PSA) \</=15ng/ml within 3 months of screening visit
  • Life expectancy of more than 10 years
  • Signed informed consent by patient
  • An understanding of the English language sufficient to understand written and verbal information about the trial and consent process

You may not qualify if:

  • Men who have had previous radiation therapy to the pelvis
  • Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
  • Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  • Men with a tumour not visible on mpMRI
  • Men with an inability to tolerate a transrectal ultrasound (TRUS)
  • Men allergic to latex
  • Men who have undergone prior significant rectal surgery preventing insertion of the transrectal ultrasound probe (decided on the type of surgery in individual cases)
  • Men who have had previous electroporation, radiofrequency ablation, High Intensity Focused Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate
  • Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within the prior 6 months. These patients may be included within the trial if deferred from consent and screening until at least 6 months following the TURP
  • Men not fit for major surgery as assessed by a Consultant Anaesthetist
  • Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
  • Presence of metal implants/stents in the urethra
  • Men with renal impairment with a Glomerular Filtration Rate (GFR) of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospitals

London, NW1 2PS, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed U HASHIM, FRCS, PhD

    UCLH NHS Foundation Trust

    STUDY CHAIR

  • Mark EMBERTON, FRCS, MD

    Division of Surgery & Interventional Science, UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2014

First Posted

November 19, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 30, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

GB(1)