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Robotic Surgery After Focal Ablation Therapy (RAFT)

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ClinicalTrials.gov Identifier: NCT03011606
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:

The toxicity of traditional prostate cancer therapies including radical surgery and external beam radiation is well known. This has prompted a move towards focal therapy where only the cancerous part of the prostate is treated.

To date, studies have demonstrated very promising outcomes following focal therapy with the majority of men maintaining their urinary and sexual function after therapy.

In a small proportion of men, disease recurs after focal therapy. The optimal treatment for men with recurrent disease after focal therapy is yet to be defined. Patients may undergo further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU) or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate is removed.

To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after focal therapy has not been formally studied.

Traditionally, the side effects of surgery and radiation therapy performed in patients that have already undergone previous prostate cancer treatment have been considerable with high rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a significant area of the prostate untreated, the investigators believe surgery after focal prostate therapy will be associated with a much lower incidence of urinary and sexual dysfunction.

The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in men that have undergone prior focal ablation therapy. In addition, the investigators wish to perform a number of basic science studies to attempt to better understand why the patient has experienced recurrent prostate cancer after focal therapy.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Robotic Surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Surgery After Focal Ablation Therapy
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robotic surgery
Single arm. All Registered patients will undergo robotic surgery
Procedure: Robotic Surgery
Robotic Surgery after Focal Ablation Therapy




Primary Outcome Measures :
  1. Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V) [ Time Frame: Up to 12 months following surgical procedure ]
  2. Toxicity profile prior to surgery [ Time Frame: Prior to surgery (at -6 to 0 weeks screening visit) ]
    This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed prior to surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.

  3. Toxicity profile following surgery [ Time Frame: Up to 12 months following surgery ]
    This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed at 3-monthly intervals for 12 months following surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.


Secondary Outcome Measures :
  1. Oncological outcome [ Time Frame: Up to 12 months following surgical procedure ]
    Will be quantified using Biochemical-free survival. Biochemical recurrence after surgery will be defined according to American Urological Association (AUA) guidance e.g. a post-surgical serum Prostate Specific Antigen (PSA) >=0.2 on 2 separate occasions.

  2. Oncological outcome [ Time Frame: Up to 12 months following surgical procedure ]
    Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Willingness to provide informed consent
  2. Males aged 18 years and over
  3. Histological confirmed recurrent/residual adenocarcinoma of the prostate with Gleason score following primary focal prostate cancer ablation therapy. Biopsy must have been performed within 6 months of screening for the study
  4. Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy
  5. Serum Prostate Specific Antigen (PSA) must be below 20
  6. Absence of metastatic disease
  7. Life expectancy ≥ 10 years
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  9. MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation therapy

Exclusion Criteria:

  1. Serious co-existing medical illness such as chronic active autoimmune disease (within the last 6 months).
  2. Other active malignancy over the last 5 years that has required systemic therapy excluding:

    1. Adjuvant therapy in the curative setting
    2. Non-melanoma skin cancer
    3. superficial transitional cell carcinoma
  3. No willingness to comply with the procedural requirements of this protocol
  4. Coagulopathy/ Cirrhosis
  5. Severe obesity defined as a BMI greater than 45
  6. Inability to tolerate general anaesthesia
  7. Prior pelvic fracture
  8. Extensive tethering of the rectum caused by prior ablation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011606


Contacts
Contact: Paul Cathcart bci-raft@qmul.ac.uk

Locations
United Kingdom
Guys and St Thomas' Hospital, London Recruiting
London, United Kingdom
Contact: Paul Cathcart         
Principal Investigator: Paul Cathcart         
Sponsors and Collaborators
Queen Mary University of London
Investigators
Study Chair: Paul Cathcart Queen Mary University London

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03011606     History of Changes
Other Study ID Numbers: 9211QM
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Queen Mary University of London:
prostate
ablation
focal
cancer