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
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)|
|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|
Experimental: Robotic surgery
Single arm. All Registered patients will undergo robotic surgery
Procedure: Robotic Surgery
Robotic Surgery after Focal Ablation Therapy
- 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 ]
- 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.
- 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.
- 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.
- 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.
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
|Contact: Paul Cathcartfirstname.lastname@example.org|
|Guys and St Thomas' Hospital, London||Recruiting|
|London, United Kingdom|
|Contact: Paul Cathcart|
|Principal Investigator: Paul Cathcart|
|Study Chair:||Paul Cathcart||Queen Mary University London|