Robotic Surgery After Focal Ablation Therapy

NCT03011606 | Completed

• 1 other identifier: 9211QM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate; ablation; focal; cancer

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  Prior to surgery (at -6 to 0 weeks screening visit)

• Toxicity profile 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.

  Up to 12 months following surgery

Secondary Outcomes (2)

• Oncological outcome

  Up to 12 months following surgical procedure

• Oncological outcome

  Up to 12 months following surgical procedure

Study Arms (1)

Robotic surgery

EXPERIMENTAL

Single arm. All Registered patients will undergo robotic surgery

Procedure: Robotic Surgery

Interventions

Robotic Surgery PROCEDURE

Robotic Surgery after Focal Ablation Therapy

Robotic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to provide informed consent
• Males aged 18 years and over
• 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
• Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy
• Serum Prostate Specific Antigen (PSA) must be below 20
• Absence of metastatic disease
• Life expectancy ≥ 10 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation therapy

You may not qualify if:

• Serious co-existing medical illness such as chronic active autoimmune disease (within the last 6 months).
• Other active malignancy over the last 5 years that has required systemic therapy excluding:
• Adjuvant therapy in the curative setting
• Non-melanoma skin cancer
• superficial transitional cell carcinoma
• No willingness to comply with the procedural requirements of this protocol
• Coagulopathy/ Cirrhosis
• Severe obesity defined as a BMI greater than 45
• Inability to tolerate general anaesthesia
• Prior pelvic fracture
• Extensive tethering of the rectum caused by prior ablation therapy

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (2)

Guys and St Thomas' Hospital, London

London, United Kingdom

Location

University College London Hospital

London, United Kingdom

Location

Related Publications (1)

• Cathcart P, Ribeiro L, Moore C, Ahmed HU, Leslie T, Arya M, Orczyk C, Hindley RG, Cahill F, Prendergast A, Coetzee C, Yogeswaran Y, Tunna K, Sooriakumaran P, Emberton M. Outcomes of the RAFT trial: robotic surgery after focal therapy. BJU Int. 2021 Oct;128(4):504-510. doi: 10.1111/bju.15432. Epub 2021 May 13.

  PMID: 33891378 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Paul Cathcart

  Queen Mary University London

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: January 5, 2017
• Study Start: February 1, 2016
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

GB (2)