Robotic Surgery After Focal Ablation Therapy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Robotic Surgery

• Registration Number: NCT03011606
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-28
• Study Start: 2016-02
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic surgery	Robotic Surgery	Single arm. All Registered patients will undergo robotic surgery

Primary Outcome Measures

Name	Time	Method
Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)	Up to 12 months following surgical procedure
Toxicity profile prior to surgery	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	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

Name	Time	Method
Oncological outcome	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.

Trial Locations

Locations (2)

Guys and St Thomas' Hospital, London; 🇬🇧 London, United Kingdom

University College London Hospital; 🇬🇧 London, United Kingdom